Clinical trial • Phase III • Oncology

ELACESTRANT for Advanced breast cancer (ER-positive, HER2-negative, ESR1-mutated)

Phase III trial of ELACESTRANT for Advanced breast cancer (ER-positive, HER2-negative, ESR1-mutated).

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Advanced breast cancer (ER-positive, HER2-negative, ESR1-mutated)
Trial Stage: Phase III
Drug Modality: Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date: 01-08-2024
First CTIS Authorization Date: 26-11-2024

Trial design

Randomised, elacestrant plus placebo (placebo described as matching white tablet with embossing "ev"/"2.5"); comparator arm is elacestrant plus placebo. doses/schedules not specified in available ctis metadata.-controlled Phase III trial in Austria, Spain, Italy and others.

Randomised: Yes
Comparator: Elacestrant plus placebo (placebo described as matching white tablet with embossing "EV"/"2.5"); comparator arm is elacestrant plus placebo. Doses/schedules not specified in available CTIS metadata.
Biomarker Stratified: True, biomarker: ESR1 mutation (patients must be ESR1-mutated)
Target Sample Size: 214

Eligibility

Recruits 214 Participants must be ≥ 18 years; the patient or his/her legal representative must be capable to understand the purpose of the study and sign written informed consent form (ICF) prior to beginning protocol procedures. Legal representative may provide consent if the patient is incapable. No other vulnerable populations are selected in the CTIS record..

Pregnancy Exclusion: Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.
Vulnerable Population: Participants must be ≥ 18 years; the patient or his/her legal representative must be capable to understand the purpose of the study and sign written informed consent form (ICF) prior to beginning protocol procedures. Legal representative may provide consent if the patient is incapable. No other vulnerable populations are selected in the CTIS record.

Inclusion criteria

{"criterion_text":"- Patient or his/her legal representative must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures."}
{"criterion_text":"- No prior chemotherapy for advanced disease is allowed."}
{"criterion_text":"- Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lyticblastic bone lesion."}
{"criterion_text":"- Willingness and ability to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue or block. If a newly obtained baseline biopsy of an accessible tumor lesion is not possible to be obtained prior randomization, an archival tissue sample will be accepted."}
{"criterion_text":"- Fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L and fasting triglycerides ≤ 2.5 times the upper limit of normal (x ULN)."}
{"criterion_text":"- Adequate bone marrow and organ function: o Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within seven days before randomization): absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥ 100.0 x109/L; and hemoglobin ≥ 9.0 g/dL. o Hepatic: Serum albumin ≥ 2.5 g/dL; total serum bilirubin < 1.5 x ULN except for patients with Gilbert’s syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN; alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 3 x ULN in patients with liver and/or bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases). o Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated by Cockcroft- Gault equation. o Coagulation: International normalized ratio (INR) ≤ 1.5 x ULN, unless that the patient meets the exception described in the exclusion criteria 16."}
{"criterion_text":"- Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 (except for toxicities not considered a safety risk for the patient at Investigator's discretion). Note: Patients with grade 2 alopecia are allowed."}
{"criterion_text":"- Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before randomization. In addition, they agree to use one highly effective method of birth control 28 days prior to start of treatment until 120 days after the last dose of study treatments. Female patients must refrain from egg cell donation/freezing and breastfeeding during this same time period."}
{"criterion_text":"- Male participants with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception 28 days prior to treatment until 120 days after the last dose of study treatments to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and 120 days after the last dose of study treatments is an acceptable practice if this is the preferred usual lifestyle of the participant."}
{"criterion_text":"- ECOG performance status of 0-1."}
{"criterion_text":"- Minimum life expectancy of ≥ 12 weeks at screening."}
{"criterion_text":"- Female or male patients ≥ 18 years of age at the time of signing ICF."}
{"criterion_text":"- Pre- or perimenopausal women, who do not meet the criteria for postmenopausal status (defined in continuation) and men must be concurrently receiving a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically) prior to study randomization and are planning to continue LHRH agonist treatment during the study. Post-menopausal women as defined by any of the following criteria: o Age ≥ 60 years; o Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH levels within the laboratory’s reference range for post-menopausal females; o Documented bilateral surgical oophorectomy."}
{"criterion_text":"- Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent."}
{"criterion_text":"- Documentation of ER[+] (≥10% positive stained cells) and HER2[-] (0–1+ by immunohistochemistry [IHC] or 2+ and negative by in situ hybridization [ISH] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as per local assessment. ER[+]/HER2[-] status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease."}
{"criterion_text":"- Patients with ESR1 mutation determined before randomization using Guardant360® CDx-CGP panel (Guardant Health) test. Note: Patients with previously determined ESR1 mutation using appropriately validated tests (such as Guardant360 CDx [Guardant Health], FoundationOne CDx, FoundationOne Liquid [Foundation Medicine Inc]) will be eligible for inclusion. This local determination can be performed either in blood or tumor samples."}
{"criterion_text":"- Radiological or objective evidence of disease progression on prior treatment with a CDK4/6 inhibitor in combination with endocrine therapy for advanced disease after at least 6 months of treatment. Patients receiving CDK4/6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after at least 12 months of treatment but no more than 12 months following CDK4/6 inhibitor treatment completion in this scenario."}
{"criterion_text":"- Patients must have previously received at least one and no more than two lines of endocrine therapy for ABC. Progression during or within 12 months of adjuvant endocrine therapy is considered as a line of endocrine therapy for advanced disease."}
{"criterion_text":"- No prior elacestrant or other investigational SERDs, PROTAC, CERAN, or novel SERM, and/or PI3K/AKT/mTOR inhibitors, including everolimus, for advanced disease are permitted. Note: Fulvestrant is permitted if treatment was administered at least 28 days before randomization."}

Exclusion criteria

{"criterion_text":"- Inability to comply with study and follow-up procedures."}
{"criterion_text":"- Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or to more than 30% of the bone marrow within four weeks prior to randomization."}
{"criterion_text":"- Major surgical procedure or significant traumatic injury within 14 days before randomization or anticipation of need for major surgery within the course of the study treatment."}
{"criterion_text":"- Clinically relevant cardiovascular/cerebrovascular disease and/or cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following: o Symptomatic pericarditis, unstable angina pectoris, documented myocardial infarction, coronary/peripheral artery bypass graft, symptomatic cardiac heart failure (CHF) (New York Heart Association [NYHA] Class II-IV), or cerebrovascular accident including transient ischemic attack within six months before study randomization."}
{"criterion_text":"- Concurrent uncontrolled atrial fibrillation, other ongoing cardiac dysrhythmias grade ≥ 2 as determined by NCI-CTCAE v.5.0, or prolonged QTcF (> 480 msec)."}
{"criterion_text":"- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited, to any of the following: o Massive lung metastatic involvement (e.g., pleural effusion, lymphangitic carcinomatosis, etc.). o Any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, post COVID-19 pulmonary fibrosis, etc.). o Any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.). o Prior pneumonectomy."}
{"criterion_text":"- History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening."}
{"criterion_text":"- Coagulopathy or any history of coagulopathy within six months before study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, patients with the following conditions will be allowed to participate: o Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to randomization. o Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than six months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to randomization."}
{"criterion_text":"- Concomitant treatment with immunosuppressive agents or chronic corticosteroids use before randomization with the following exceptions: topical applications, inhaled sprays, eye drops, mouthwash, or local injections are allowed. Patients on stable low dose of corticosteroids (£ 10 mg/day of prednisone or equivalent) for at least two weeks before randomization are also permitted."}
{"criterion_text":"- Unable or unwilling to avoid over-the-counter medications, dietary/herbal supplements (e.g., St. John’s wort), and/or foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate/strong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and/or foods are discontinued for at least five halflives or 14 days (whichever is shorter) prior to randomization and for the duration of the study"}
{"criterion_text":"- Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol."}
{"criterion_text":"- Formal contraindication to endocrine therapy defined as visceral crisis and/or rapidly or symptomatic progressive visceral disease."}
{"criterion_text":"- Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Any other active uncontrolled infection at the time of screening is not allowed."}
{"criterion_text":"- Known substance abuse or any other concurrent severe and/or uncontrolled psychiatric or medical condition that would, in the Investigator’s judgment, contraindicate patient participation."}
{"criterion_text":"- Current participation in another therapeutic clinical trial."}
{"criterion_text":"- Treatment with approved or investigational cancer therapy within 14 days prior to randomization except for fulvestrant that must be administered at least 28 days before randomization."}
{"criterion_text":"- Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anti-convulsants and steroids for at least 14 days before randomization."}
{"criterion_text":"- Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion)."}
{"criterion_text":"- Concurrent malignancy or malignancy within three years before randomization with the exception of carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required."}
{"criterion_text":"- Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances."}
{"criterion_text":"- History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass) or results in the inability or unwillingness to swallow pills."}

Endpoints

Primary endpoints

{"endpoint_text":"- PFS, defined as the period from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by BIRC through the use of RECIST v.1.1.","definition_or_measurement_approach":"Assessed by a Blinded Imaging Review Committee (BIRC) using RECIST v1.1; PFS defined as time from randomization to first documented disease progression or death from any cause."}

Secondary endpoints

{"endpoint_text":"- Investigator-assessed PFS, defined as the period from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally through the use of RECIST v.1.1.","definition_or_measurement_approach":"Local investigator assessment using RECIST v1.1; time from randomization to progression or death."}
{"endpoint_text":"- OS, defined as the period from randomization to death from any cause, as determined locally by the Investigator.","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause as recorded by investigator/local site."}
{"endpoint_text":"- ORR, defined as the rate of patients with a best overall response (BOR) of complete response (CR) or partial response (PR), based on a BIRC and local Investigator assessment through the use of RECIST v.1.1.","definition_or_measurement_approach":"Objective response rate based on BOR of CR or PR assessed by BIRC and locally per RECIST v1.1."}
{"endpoint_text":"- CBR, defined as the rate of patients with an objective response (CR or PR), or stable disease for at least 24 weeks, based on a BIRC and local Investigator assessment through the use of RECIST v.1.1.","definition_or_measurement_approach":"Clinical benefit rate = CR or PR or stable disease ≥24 weeks assessed by BIRC and local investigator per RECIST v1.1."}
{"endpoint_text":"- TTR, defined as the period from randomization to time of the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a BOR of CR or PR, based on a BIRC and local Investigator assessment through the use of RECIST v.1.1.","definition_or_measurement_approach":"Time to response measured from randomization to first objective tumor response (≥30% tumor shrinkage) among responders assessed by BIRC and locally per RECIST v1.1."}
{"endpoint_text":"- DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, based on a BIRC and local Investigator assessment through the use of RECIST v.1.1.","definition_or_measurement_approach":"Duration of response measured from first documented response to progression or death, per BIRC and local investigator using RECIST v1.1."}
{"endpoint_text":"- Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, based on a BIRC and local Investigator assessment through the use of RECIST v.1.1.","definition_or_measurement_approach":"Computed per RECIST v1.1 as maximal percent change from baseline in sum of target lesion diameters by BIRC and local assessment."}
{"endpoint_text":"- Safety and tolerability, assessed by adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose modifications, clinical laboratory parameters (i. e., hematology, chemistry, lipid panel, and coagulation), electrocardiograms (ECGs), performance status, and vital signs.","definition_or_measurement_approach":"Safety assessed via standard recording of AEs/SAEs/TEAEs, dose modifications, labs, ECGs, performance status, and vital signs as per protocol and CTCAE v5.0."}
{"endpoint_text":"- Changes from baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the EORTC Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR42) scales, and symptoms scores","definition_or_measurement_approach":"Patient-reported HRQoL measures assessed using EQ-5D-5L, EORTC QLQ-C30 and EORTC QLQ-BR42 questionnaires; changes from baseline will be analyzed."}

Recruitment

Digital Remote Recruitment: True, social media information materials referenced (e.g., 'K2_Recruitment material_Information in social media') indicating digital outreach; country-specific social media material available for Spain.
Planned Sample Size: 214
Recruitment Window Months: 37
Consent Approach: Written informed consent (ICF) is required prior to any protocol-specific procedures; the patient or his/her legal representative may sign the ICF. Consent forms and subject information sheets are provided in multiple country/language-specific versions (documents listed for DE, ES, FR, IT, GR, CZ, and English), and pre-screening and pregnancy-specific ICF materials are provided where applicable.

Methods

Site-based recruitment at participating hospitals/oncology clinics as per recruitment arrangements documents (country-specific site lists provided).
Social media outreach (document titled 'K2_Recruitment material_Information in social media' indicates use of social media; Spain-specific recruitment material present).

Geography

Total Number Of Sites: 97
Total Number Of Participants: 214

Austria

Earliest CTIS Part Ii Submission Date: 28-10-2024
Latest Decision Or Authorization Date: 02-12-2024
Processing Time Days: 35
Number Of Sites: 4
Number Of Participants: 5

Sites

Site Name: Priv. Doz. Dr. Michael Hubalek
Department Name: Gynecology + Breast Center
Principal Investigator Name: Michael Martin Hubalek
Principal Investigator Email: michael@hubalek.at
Contact Person Name: Michael Martin Hubalek
Contact Person Email: michael@hubalek.at

Site Name: Ordensklinikum Linz GmbH
Department Name: Internal Medicine I: Medical Oncology and Hematology
Principal Investigator Name: Clemens Dormann
Principal Investigator Email: clemens.dormann@ordensklinikum.at
Contact Person Name: Clemens Dormann
Contact Person Email: clemens.dormann@ordensklinikum.at

Site Name: Medizinische Universitaet Innsbruck
Department Name: Department of Gynecology and Obsterics
Principal Investigator Name: Daniel Egle
Principal Investigator Email: daniel.egle@tirol-kliniken.at
Contact Person Name: Daniel Egle
Contact Person Email: daniel.egle@tirol-kliniken.at

Site Name: Medical University Of Vienna
Department Name: Department of Medicine I; Division of Oncology
Principal Investigator Name: Rupert Bartsch
Principal Investigator Email: rupert.bartsch@meduniwien.ac.at
Contact Person Name: Rupert Bartsch
Contact Person Email: rupert.bartsch@meduniwien.ac.at

Spain

Earliest CTIS Part Ii Submission Date: 20-09-2024
Latest Decision Or Authorization Date: 02-12-2024
Processing Time Days: 73
Number Of Sites: 39
Number Of Participants: 79

Sites

Site Name: Hospital San Pedro De Alcantara
Department Name: Medical Oncology
Principal Investigator Name: Santiago Gonzalez Santiago
Principal Investigator Email: santigsanti@gmail.com
Contact Person Name: Santiago Gonzalez Santiago
Contact Person Email: santigsanti@gmail.com

Site Name: Hospital General Universitario De Valencia
Department Name: Medical Oncology
Principal Investigator Name: Vega Iranzo
Principal Investigator Email: iranzo_veg@gva.es
Contact Person Name: Vega Iranzo
Contact Person Email: iranzo_veg@gva.es

Site Name: Hospital Universitario Clinico San Cecilio
Department Name: Medical Oncology
Principal Investigator Name: Isabel Blancas
Principal Investigator Email: iblancas@ugr.es
Contact Person Name: Isabel Blancas
Contact Person Email: iblancas@ugr.es

Site Name: Hospital Clinico Universitario Lozano Blesa
Department Name: Medical Oncology
Principal Investigator Name: Raquel Andres
Principal Investigator Email: andresraquelc@gmail.com
Contact Person Name: Raquel Andres
Contact Person Email: andresraquelc@gmail.com

Site Name: Consorcio Hospitalario Provincial De Castellon
Department Name: Medical Oncology
Principal Investigator Name: Eduardo Martínez de Dueñas
Principal Investigator Email: eduardo.martinez@hospitalprovincial.es
Contact Person Name: Eduardo Martínez de Dueñas
Contact Person Email: eduardo.martinez@hospitalprovincial.es

Site Name: Hospital Universitario De La Ribera
Department Name: Medical Oncology
Principal Investigator Name: Athanasios Pouptsis
Principal Investigator Email: th.pouptsis@gmail.com
Contact Person Name: Athanasios Pouptsis
Contact Person Email: th.pouptsis@gmail.com

Site Name: Hospital Arnau De Vilanova De Valencia
Department Name: Medical Oncology
Principal Investigator Name: Vicente Caranana Ballerini
Principal Investigator Email: vicentecaranyana@gmail.com
Contact Person Name: Vicente Caranana Ballerini
Contact Person Email: vicentecaranyana@gmail.com

Site Name: Hospital Universitario De Jaen
Department Name: Medical Oncology
Principal Investigator Name: Rocio Urbano Cubero
Principal Investigator Email: oncopsr@yahoo.es
Contact Person Name: Rocio Urbano Cubero
Contact Person Email: oncopsr@yahoo.es

Site Name: Hospital Universitario Marques De Valdecilla
Department Name: Medical Oncology
Principal Investigator Name: Carmen Hinojo
Principal Investigator Email: carmen.hinojo@scsalud.es
Contact Person Name: Carmen Hinojo
Contact Person Email: carmen.hinojo@scsalud.es

Site Name: Hospital Universitario Hm Sanchinarro
Department Name: Medical Oncology
Principal Investigator Name: Raquel Bratos Lorenzo
Principal Investigator Email: rbratos@hmhospitales.com
Contact Person Name: Raquel Bratos Lorenzo
Contact Person Email: rbratos@hmhospitales.com

Site Name: Complexo Hospitalario Universitario De Santiago
Department Name: Medical Oncology
Principal Investigator Name: Juan Cueva
Principal Investigator Email: juan.fernando.cueva.banuelos@sergas.es
Contact Person Name: Juan Cueva
Contact Person Email: juan.fernando.cueva.banuelos@sergas.es

Site Name: Hospital Universitario De Canarias
Department Name: Medical Oncology
Principal Investigator Name: Josefina Cruz Jurado
Principal Investigator Email: jcruzjurado@gmail.com
Contact Person Name: Josefina Cruz Jurado
Contact Person Email: jcruzjurado@gmail.com

Site Name: University Hospital Son Espases
Department Name: Medical Oncology
Principal Investigator Name: Antonia Perello
Principal Investigator Email: antonia.perellom@ssib.es
Contact Person Name: Antonia Perello
Contact Person Email: antonia.perellom@ssib.es

Site Name: Hospital Universitario Virgen De La Macarena
Department Name: Medical Oncology
Principal Investigator Name: Luis de la Cruz Merino
Principal Investigator Email: ldelacruzmerino@gmail.com
Contact Person Name: Luis de la Cruz Merino
Contact Person Email: ldelacruzmerino@gmail.com

Site Name: Hospital Universitario De Burgos
Department Name: Medical Oncology
Principal Investigator Name: Blanca Hernando Fernandez de Aranguiz
Principal Investigator Email: bhernando@saludcastillayleon.es
Contact Person Name: Blanca Hernando Fernandez de Aranguiz
Contact Person Email: bhernando@saludcastillayleon.es

Site Name: Institut Catala D'oncologia
Department Name: Medical Oncology
Principal Investigator Name: Laia Boronat Ruiz
Principal Investigator Email: lboronat@iconcologia.net
Contact Person Name: Laia Boronat Ruiz
Contact Person Email: lboronat@iconcologia.net

Site Name: Hospital Universitario Puerta De Hierro De Majadahonda
Department Name: Medical Oncology
Principal Investigator Name: Blanca Cantos Sanchez de Ibarguen
Principal Investigator Email: bcantos.hpth@salud.madrid.org
Contact Person Name: Blanca Cantos Sanchez de Ibarguen
Contact Person Email: bcantos.hpth@salud.madrid.org

Site Name: Hospital Universitario De Navarra
Department Name: Medical Oncology
Principal Investigator Name: Susana de la Cruz
Principal Investigator Email: Susana.delacruz.sanchez@navarra.es
Contact Person Name: Susana de la Cruz
Contact Person Email: Susana.delacruz.sanchez@navarra.es

Site Name: Hospital Clinic De Barcelona
Department Name: Medical Oncology
Principal Investigator Name: Isabel Garcia
Principal Investigator Email: IGARCIAF@recerca.clinic.cat
Contact Person Name: Isabel Garcia
Contact Person Email: IGARCIAF@recerca.clinic.cat

Site Name: Hospital Beata Maria Ana
Department Name: Medical Oncology
Principal Investigator Name: Cristina Saavedra
Principal Investigator Email: cristina.saavedra@iobmadrid.com
Contact Person Name: Cristina Saavedra
Contact Person Email: cristina.saavedra@iobmadrid.com

Site Name: Complejo Hospitalario Universitario Insular Materno Infantil
Department Name: Medical Oncology
Principal Investigator Name: Elisenda Llabres Valenti
Principal Investigator Email: elisenda.llabres@gmail.com
Contact Person Name: Elisenda Llabres Valenti
Contact Person Email: elisenda.llabres@gmail.com

Site Name: Hospital Quironsalud Sagrado Corazon
Department Name: Medical Oncology
Principal Investigator Name: Maria Valero
Principal Investigator Email: m.valero@oncoavanze.es
Contact Person Name: Maria Valero
Contact Person Email: m.valero@oncoavanze.es

Site Name: Hospital Universitario 12 De Octubre
Department Name: Medical Oncology
Principal Investigator Name: Pablo Tolosa
Principal Investigator Email: pablotolosa_7@hotmail.com
Contact Person Name: Pablo Tolosa
Contact Person Email: pablotolosa_7@hotmail.com

Site Name: Hospital Clinico Universitario De Valencia
Department Name: Medical Oncology
Principal Investigator Name: Begoña Bermejo de las Heras
Principal Investigator Email: begobermejo@gmail.com
Contact Person Name: Begoña Bermejo de las Heras
Contact Person Email: begobermejo@gmail.com

Site Name: Hospital Universitario De Leon
Department Name: Medical Oncology
Principal Investigator Name: Mariana Lopez Flores
Principal Investigator Email: mlopezfl@saludcastillayleon.es
Contact Person Name: Mariana Lopez Flores
Contact Person Email: mlopezfl@saludcastillayleon.es

Site Name: Hospital Universitario San Juan De Alicante
Department Name: Medical Oncology
Principal Investigator Name: Asuncion Juarez
Principal Investigator Email: juamaras@yahoo.es
Contact Person Name: Asuncion Juarez
Contact Person Email: juamaras@yahoo.es

Site Name: Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name: Medical Oncology
Principal Investigator Name: Pablo Alvarez Rodriguez
Principal Investigator Email: pablo.alvarez@cog.es
Contact Person Name: Pablo Alvarez Rodriguez
Contact Person Email: pablo.alvarez@cog.es

Site Name: Hospital Universitario Basurto
Department Name: Medical Oncology
Principal Investigator Name: Laia Boronat Ruiz
Principal Investigator Email: lboronat@iconcologia.net
Contact Person Name: Laia Boronat Ruiz
Contact Person Email: lboronat@iconcologia.net

Site Name: Hospital Universitario La Paz
Department Name: Medical Oncology
Principal Investigator Name: Virginia Martinez Marin
Principal Investigator Email: virginiamartinezmarin029@gmail.com
Contact Person Name: Virginia Martinez Marin
Contact Person Email: virginiamartinezmarin029@gmail.com

Site Name: Hospital General Universitario Dr. Balmis
Department Name: Medical Oncology
Principal Investigator Name: Jose J. Ponce Lorenzo
Principal Investigator Email: joseponcelorenzo@hotmail.com
Contact Person Name: Jose J. Ponce Lorenzo
Contact Person Email: joseponcelorenzo@hotmail.com

Site Name: Hospital Universitario Ramon Y Cajal
Department Name: Medical Oncology
Principal Investigator Name: Alfonso Cortes Salgado
Principal Investigator Email: acsalgado86@gmail.com
Contact Person Name: Alfonso Cortes Salgado
Contact Person Email: acsalgado86@gmail.com

Site Name: Salut Sant Joan De Reus
Department Name: Medical Oncology
Principal Investigator Name: Alba Cochs
Principal Investigator Email: alba.cochs@salutsantjoan.cat
Contact Person Name: Alba Cochs
Contact Person Email: alba.cochs@salutsantjoan.cat

Site Name: MD Anderson Cancer Center
Department Name: Medical Oncology
Principal Investigator Name: Laura Garcia Estevez
Principal Investigator Email: lgestevez@mdanderson.es
Contact Person Name: Laura Garcia Estevez
Contact Person Email: lgestevez@mdanderson.es

Site Name: Hospital Universitari Vall D Hebron
Department Name: Medical Oncology
Principal Investigator Name: Esther Zamora
Principal Investigator Email: ezamora@vhio.net
Contact Person Name: Esther Zamora
Contact Person Email: ezamora@vhio.net

Site Name: University Hospital Virgen Del Rocio S.L.
Department Name: Medical Oncology
Principal Investigator Name: Manuel Ruiz
Principal Investigator Email: ruizsabater@gmail.com
Contact Person Name: Manuel Ruiz
Contact Person Email: ruizsabater@gmail.com

Site Name: Hospital Universitari Dexeus Grupo Quironsalud
Department Name: Medical Oncology
Principal Investigator Name: Laia Garrigos Cubells
Principal Investigator Email: laia.garrigos@ibcc.clinic
Contact Person Name: Laia Garrigos Cubells
Contact Person Email: laia.garrigos@ibcc.clinic

Site Name: Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name: Medical Oncology
Principal Investigator Name: Serafin Morales
Principal Investigator Email: serafinmorales01@gmail.com
Contact Person Name: Serafin Morales
Contact Person Email: serafinmorales01@gmail.com

Site Name: University Clinical Hospital Virgen De La Arrixaca
Department Name: Medical Oncology
Principal Investigator Name: Jose Luis Alonso Romero
Principal Investigator Email: josel.alonso2@carm.es
Contact Person Name: Jose Luis Alonso Romero
Contact Person Email: josel.alonso2@carm.es

Site Name: Hospital Del Mar
Department Name: Medical Oncology
Principal Investigator Name: Tamara Martos Cardenas
Principal Investigator Email: tmartoscardenas@psmar.cat
Contact Person Name: Tamara Martos Cardenas
Contact Person Email: tmartoscardenas@psmar.cat

Italy

Earliest CTIS Part Ii Submission Date: 25-10-2024
Latest Decision Or Authorization Date: 26-11-2024
Processing Time Days: 32
Number Of Sites: 13
Number Of Participants: 38

Sites

Site Name: Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name: Dipartimento Oncologico
Principal Investigator Name: Giacomo Allegrini
Principal Investigator Email: giacomo.allegrini@uslnordovest.toscana.it
Contact Person Name: Giacomo Allegrini
Contact Person Email: giacomo.allegrini@uslnordovest.toscana.it

Site Name: Istituto Europeo Di Oncologia S.r.l.
Department Name: Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Principal Investigator Name: Carmen Criscitiello
Principal Investigator Email: carmen.criscitiello@ieo.it
Contact Person Name: Carmen Criscitiello
Contact Person Email: carmen.criscitiello@ieo.it

Site Name: IRCCS Ospedale Sacro Cuore Don Calabria
Department Name: Medical Oncology Unit
Principal Investigator Name: Stefania Gori
Principal Investigator Email: Stefania.gori@sacrocuore.it
Contact Person Name: Stefania Gori
Contact Person Email: Stefania.gori@sacrocuore.it

Site Name: IRCCS Ospedale Policlinico San Martino
Department Name: Clinical Oncology Unit
Principal Investigator Name: Lucia Del Mastro
Principal Investigator Email: lucia.delmastro@hsanmartino.it
Contact Person Name: Lucia Del Mastro
Contact Person Email: lucia.delmastro@hsanmartino.it

Site Name: Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name: Division of Oncology
Principal Investigator Name: Alessandra Gennari
Principal Investigator Email: alessandra.gennari@med.uniupo.it
Contact Person Name: Alessandra Gennari
Contact Person Email: alessandra.gennari@med.uniupo.it

Site Name: Cliniche Gavazzeni S.p.A.
Department Name: Oncology Department
Principal Investigator Name: Fabio Conforti
Principal Investigator Email: fabio.conforti@gavazzeni.it
Contact Person Name: Fabio Conforti
Contact Person Email: fabio.conforti@gavazzeni.it

Site Name: Azienda Ospedaliero Universitaria Di Modena
Department Name: SSD DH Oncologico
Principal Investigator Name: Federico Piacentini
Principal Investigator Email: federico.piacentini@unimore.it
Contact Person Name: Federico Piacentini
Contact Person Email: federico.piacentini@unimore.it

Site Name: Fondazione IRCCS San Gerardo Dei Tintori
Department Name: U.O.C. Centro di ricerca di Fase I
Principal Investigator Name: Marina Elena Cazzaniga
Principal Investigator Email: marinaelena.cazzaniga@irccs-sangerardo.it
Contact Person Name: Marina Elena Cazzaniga
Contact Person Email: marinaelena.cazzaniga@irccs-sangerardo.it

Site Name: Azienda Ospedaliero-Universitaria Di Cagliari
Department Name: SC Oncologia Medica
Principal Investigator Name: Mario Scartozzi
Principal Investigator Email: dir.generale@aoucagliari.it
Contact Person Name: Mario Scartozzi
Contact Person Email: dir.generale@aoucagliari.it

Site Name: Azienda Ospedaliero Universitaria Careggi
Department Name: Radiation oncology unit
Principal Investigator Name: Icro Meattini
Principal Investigator Email: icro.meattini@unifi.it
Contact Person Name: Icro Meattini
Contact Person Email: icro.meattini@unifi.it

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: U.O.C. of Oncological gynaecology – Breast Cancer Unit
Principal Investigator Name: Ida Paris
Principal Investigator Email: ida.paris@policlinicogemelli.it
Contact Person Name: Ida Paris
Contact Person Email: ida.paris@policlinicogemelli.it

Site Name: Azienda Unita Sanitaria Locale Di Piacenza
Department Name: Dipartimento di Oncoematologia, UOC oncologia medica
Principal Investigator Name: Serena Madaro
Principal Investigator Email: s.madaro@ausl.pc.it
Contact Person Name: Serena Madaro
Contact Person Email: s.madaro@ausl.pc.it

Site Name: IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name: Oncology Division
Principal Investigator Name: Michelino De Laurentiis
Principal Investigator Email: m.delaurentiis@istitutotumori.na.it
Contact Person Name: Michelino De Laurentiis
Contact Person Email: m.delaurentiis@istitutotumori.na.it

Greece

Earliest CTIS Part Ii Submission Date: 13-11-2024
Latest Decision Or Authorization Date: 26-11-2024
Processing Time Days: 13
Number Of Sites: 12
Number Of Participants: 20

Sites

Site Name: General Hospital Of Patras Agios Andreas
Department Name: Oncology Unit
Principal Investigator Name: Athina Christopoulou
Principal Investigator Email: athinachristo@hotmail.com
Contact Person Name: Athina Christopoulou
Contact Person Email: athinachristo@hotmail.com

Site Name: University General Hospital Of Ioannina
Department Name: Oncology Department
Principal Investigator Name: Davide Mauri
Principal Investigator Email: dvd.mauri@gmail.com
Contact Person Name: Davide Mauri
Contact Person Email: dvd.mauri@gmail.com

Site Name: 251 Air Force General Hospital
Department Name: Oncology Department
Principal Investigator Name: Vasileios Ramfidis
Principal Investigator Email: ramfidis@gmail.com
Contact Person Name: Vasileios Ramfidis
Contact Person Email: ramfidis@gmail.com

Site Name: Athens Medical Center S.A.
Department Name: 3rd Department of Oncology
Principal Investigator Name: Konstantinos Papazisis
Principal Investigator Email: k.papazisis@oncomedicare.com
Contact Person Name: Konstantinos Papazisis
Contact Person Email: k.papazisis@oncomedicare.com

Site Name: Metropolitan Hospital
Department Name: 4th Department of Oncology
Principal Investigator Name: Helena Linardou
Principal Investigator Email: elinardou@otenet.gr
Contact Person Name: Helena Linardou
Contact Person Email: elinardou@otenet.gr

Site Name: University General Hospital Of Alexandroupoli
Department Name: Department of Medical Oncology
Principal Investigator Name: Dimitrios Matthaios
Principal Investigator Email: matthaiosdimitr@hotmail.com
Contact Person Name: Dimitrios Matthaios
Contact Person Email: matthaiosdimitr@hotmail.com

Site Name: General University Hospital Of Larissa
Department Name: Department of Medical Oncology
Principal Investigator Name: Athanasios Kotsakis
Principal Investigator Email: thankotsakis@hotmail.com
Contact Person Name: Athanasios Kotsakis
Contact Person Email: thankotsakis@hotmail.com

Site Name: University General Hospital Attikon
Department Name: 2nd Propaedeutic Internal Medicine Clinic, Oncology Unit
Principal Investigator Name: Amanda Psyrri
Principal Investigator Email: psyrri237@yahoo.com
Contact Person Name: Amanda Psyrri
Contact Person Email: psyrri237@yahoo.com

Site Name: Metropolitan Hospital
Department Name: 1st Department of Oncology
Principal Investigator Name: Dimitrios Bafaloukos
Principal Investigator Email: dimmp@otenet.gr
Contact Person Name: Dimitrios Bafaloukos
Contact Person Email: dimmp@otenet.gr

Site Name: Euromedica General Clinic Of Thessaloniki
Department Name: Oncology Unit
Principal Investigator Name: Konstantinos Papazisis
Principal Investigator Email: k.papazisis@oncomedicare.com
Contact Person Name: Konstantinos Papazisis
Contact Person Email: k.papazisis@oncomedicare.com

Site Name: Areteio Hospital
Department Name: Oncology Unit
Principal Investigator Name: Flora Zagouri
Principal Investigator Email: florazagouri@yahoo.co.uk
Contact Person Name: Flora Zagouri
Contact Person Email: florazagouri@yahoo.co.uk

Site Name: University General Hospital Of Heraklion
Department Name: Department of Medical Oncology
Principal Investigator Name: Dimitrios Mavroudis
Principal Investigator Email: medoncsec@med.uoc.gr
Contact Person Name: Dimitrios Mavroudis
Contact Person Email: medoncsec@med.uoc.gr

Germany

Earliest CTIS Part Ii Submission Date: 17-09-2024
Latest Decision Or Authorization Date: 27-11-2024
Processing Time Days: 71
Number Of Sites: 11
Number Of Participants: 18

Sites

Site Name: Franziskus Hospital Harderberg
Department Name: Oncology and Hematology
Principal Investigator Name: Kerstin Luedtke-Heckenkamp
Principal Investigator Email: kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de
Contact Person Name: Kerstin Luedtke-Heckenkamp
Contact Person Email: kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de

Site Name: Klinikum Worms gGmbH
Department Name: Frauenklinik
Principal Investigator Name: Sebastian Zuefle
Principal Investigator Email: sebastian.zuefle@klinikum-worms.de
Contact Person Name: Sebastian Zuefle
Contact Person Email: sebastian.zuefle@klinikum-worms.de

Site Name: Universitaetsklinikum Duesseldorf AöR
Department Name: Konservative gynaekologische Onkologie
Principal Investigator Name: Eugen Ruckhaeberle
Principal Investigator Email: eugen.ruckhaeberle@med.uni-duesseldorf.de
Contact Person Name: Eugen Ruckhaeberle
Contact Person Email: eugen.ruckhaeberle@med.uni-duesseldorf.de

Site Name: KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name: Multidisciplinary Breast Unit
Principal Investigator Name: Sherko Kuemmel
Principal Investigator Email: s.kuemmel@kem-med.com
Contact Person Name: Sherko Kuemmel
Contact Person Email: s.kuemmel@kem-med.com

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: Gynaekologische Onkologie
Principal Investigator Name: Carlo Fremd
Principal Investigator Email: carlo.fremd@med.uni-heidelberg.de
Contact Person Name: Carlo Fremd
Contact Person Email: carlo.fremd@med.uni-heidelberg.de

Site Name: Haematologie-Onkologie im Zentrum MVZ GmbH
Department Name: Haematologie
Principal Investigator Name: Bernhard Heinrich
Principal Investigator Email: bernhard.heinrich@hop-augsburg.de
Contact Person Name: Bernhard Heinrich
Contact Person Email: bernhard.heinrich@hop-augsburg.de

Site Name: Klinikum Aschaffenburg-Alzenau gGmbH
Department Name: MVZ am Klinikum Onkologie
Principal Investigator Name: Manfred Welslau
Principal Investigator Email: onko@mvz-klinikum-ab.de
Contact Person Name: Manfred Welslau
Contact Person Email: onko@mvz-klinikum-ab.de

Site Name: Staedtisches Klinikum Dessau
Department Name: Frauenklinik
Principal Investigator Name: Hermann Voss
Principal Investigator Email: hermann.voss@klinikum-dessau.de
Contact Person Name: Hermann Voss
Contact Person Email: hermann.voss@klinikum-dessau.de

Site Name: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Department Name: Klinik fuer Senologie
Principal Investigator Name: Katja Krauss
Principal Investigator Email: katja.krauss@brustzentrum-rhein-ruhr.com
Contact Person Name: Katja Krauss
Contact Person Email: katja.krauss@brustzentrum-rhein-ruhr.com

Site Name: Universitaetsklinikum Essen AöR
Department Name: innere Klinik (Tumorforschung)
Principal Investigator Name: Anja Welt
Principal Investigator Email: Anja.Welt@uk-essen.de
Contact Person Name: Anja Welt
Contact Person Email: Anja.Welt@uk-essen.de

Site Name: Charite Universitaetsmedizin Berlin KöR
Department Name: Klinik für Gynaekologie
Principal Investigator Name: Verena Kiver
Principal Investigator Email: verena.kiver@charite.de
Contact Person Name: Verena Kiver
Contact Person Email: verena.kiver@charite.de

France

Earliest CTIS Part Ii Submission Date: 15-11-2024
Latest Decision Or Authorization Date: 28-11-2024
Processing Time Days: 13
Number Of Sites: 10
Number Of Participants: 36

Sites

Site Name: Polyclinique Bordeaux Nord Aquitaine
Department Name: Oncology
Principal Investigator Name: Nadine Dohollou
Principal Investigator Email: n.dohollou@gor.bordeauxnord.com
Contact Person Name: Nadine Dohollou
Contact Person Email: n.dohollou@gor.bordeauxnord.com

Site Name: Oncopole Claudius Regaud
Department Name: Oncology
Principal Investigator Name: Florence Dalenc
Principal Investigator Email: dalenc.Florence@iuct-oncopole.fr
Contact Person Name: Florence Dalenc
Contact Person Email: dalenc.Florence@iuct-oncopole.fr

Site Name: Institut De Cancerologie De Lorraine
Department Name: Oncology
Principal Investigator Name: Vincent Massard
Principal Investigator Email: v.massard@nancy.unicancer.fr
Contact Person Name: Vincent Massard
Contact Person Email: v.massard@nancy.unicancer.fr

Site Name: Hopital Prive Des Cotes D'armor
Department Name: Oncology
Principal Investigator Name: Anne Claire Hardy Bessard
Principal Investigator Email: ac.hardy@cario-sante.fr
Contact Person Name: Anne Claire Hardy Bessard
Contact Person Email: ac.hardy@cario-sante.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Oncology
Principal Investigator Name: Marc Antoine Benderra
Principal Investigator Email: marc-antoine.benderra@aphp.fr
Contact Person Name: Marc Antoine Benderra
Contact Person Email: marc-antoine.benderra@aphp.fr

Site Name: Institut De Cancerologie Strasbourg Europe
Department Name: Oncology
Principal Investigator Name: Thierry Petit
Principal Investigator Email: tpetit@icans.eu
Contact Person Name: Thierry Petit
Contact Person Email: tpetit@icans.eu

Site Name: Centr Georges Francois Leclerc
Department Name: Oncology
Principal Investigator Name: Sylvain Ladoire
Principal Investigator Email: sladoire@cgfl.fr
Contact Person Name: Sylvain Ladoire
Contact Person Email: sladoire@cgfl.fr

Site Name: Institut Bergonie
Department Name: Oncology
Principal Investigator Name: Monica Arnedos
Principal Investigator Email: m.arnedos@bordeaux.unicancer.fr
Contact Person Name: Monica Arnedos
Contact Person Email: m.arnedos@bordeaux.unicancer.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Oncology
Principal Investigator Name: Gilles Freyer
Principal Investigator Email: gilles.freyer@chu-st-etienne.fr
Contact Person Name: Gilles Freyer
Contact Person Email: gilles.freyer@chu-st-etienne.fr

Site Name: Hospices Civils De Lyon
Department Name: Oncology
Principal Investigator Name: Gilles Freyer
Principal Investigator Email: gilles.freyer@chu-lyon.fr
Contact Person Name: Gilles Freyer
Contact Person Email: gilles.freyer@chu-lyon.fr

Czechia

Earliest CTIS Part Ii Submission Date: 29-10-2024
Latest Decision Or Authorization Date: 27-11-2024
Processing Time Days: 29
Number Of Sites: 8
Number Of Participants: 18

Sites

Site Name: Masarykuv Onkologicky Ustav
Department Name: Oddělení klinické onkologie
Principal Investigator Name: Miloš Holánek
Principal Investigator Email: holanek@mou.cz
Contact Person Name: Miloš Holánek
Contact Person Email: holanek@mou.cz

Site Name: Abex Zlin spol. s r.o.
Department Name: Onkologické oddělení
Principal Investigator Name: Michaela Zábojníková
Principal Investigator Email: zabojnikova@bnzlin.cz
Contact Person Name: Michaela Zábojníková
Contact Person Email: zabojnikova@bnzlin.cz

Site Name: University Hospital Olomouc
Department Name: Klinika onkologie a radioterapie
Principal Investigator Name: Adam Paulik
Principal Investigator Email: adam.paulik@fnhk.cz
Contact Person Name: Adam Paulik
Contact Person Email: adam.paulik@fnhk.cz

Site Name: Fakultni Nemocnice V Motole
Department Name: Onkologická klinika
Principal Investigator Name: Adela Danesh
Principal Investigator Email: adela.danesh@fnmotol.cz
Contact Person Name: Adela Danesh
Contact Person Email: adela.danesh@fnmotol.cz

Site Name: University Hospital Olomouc
Department Name: Onkologická klinika
Principal Investigator Name: Bohuslav Melichar
Principal Investigator Email: bohuslav.melichar@fnol.cz
Contact Person Name: Bohuslav Melichar
Contact Person Email: bohuslav.melichar@fnol.cz

Site Name: Krajska nemocnice Liberec a.s.
Department Name: Komplexní onkologické centrum
Principal Investigator Name: Kristián Hrušák
Principal Investigator Email: kristian.hrusak@nemlib.cz
Contact Person Name: Kristián Hrušák
Contact Person Email: kristian.hrusak@nemlib.cz

Site Name: NH Hospital a.s.
Department Name: Onkologický stacionář
Principal Investigator Name: Martin Šmakal
Principal Investigator Email: msmakal@gmail.com
Contact Person Name: Martin Šmakal
Contact Person Email: msmakal@gmail.com

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: Onkologická klinika
Principal Investigator Name: Martina Zimovjanová
Principal Investigator Email: martina.zimovjanova@vfn.cz
Contact Person Name: Martina Zimovjanová
Contact Person Email: martina.zimovjanova@vfn.cz

Sponsor

Primary sponsor

Full Name: Medica Scientia Innovation Research S.L.
Organisation Type: Pharmaceutical company
Country Of Registered Address: Spain

Contract research organisations

Name: Optimapharm Greece Consulting Research Single Member S.A.
Responsibilities: sponsorDuties codes: 1,12 (listed as third party with sponsor duties)

Third parties

{"country":"Greece","full_name":"Optimapharm Greece Consulting Research Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12","organisation_type":"Pharmaceutical company"}
{"country":"","full_name":"Berlin-Chemie AG","duties_or_roles":"Monetary support (listed as source of monetary support)","organisation_type":""}

Co-sponsors

Stemline Therapeutics Inc.

Investigational products

Investigational Product Name: ORSERDU 345 mg film-coated tablets
Active Substance: ELACESTRANT
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised (EU marketing authorisation EU/1/23/1757/002)
Maximum Dose: 345 mg (maxDailyDoseAmount)

Investigational Product Name: ORSERDU 86 mg film-coated tablets
Active Substance: ELACESTRANT
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised (EU marketing authorisation EU/1/23/1757/001)
Maximum Dose: 86 mg (product-specific maxDailyDoseAmount)

Investigational Product Name: Everolimus-ratiopharm® 2,5 mg Tabletten
Active Substance: EVEROLIMUS
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised (marketingAuthNumber: 97411.00.00)
Maximum Dose: 7.5 mg (maxDailyDoseAmount)

Investigational Product Name: The investigational product is as follows: white tablets, elongated, flat, rounded edges, about 10 mm long and 4 mm wide, with the embossing "EV" on one side and "2.5" on the other side. The list of excipients of Placebo tablet is as follows: Lactose monohydrate, Polyplasdone, Cellulose microcrystalline, Magnesium stearate, Hypromellose.
Modality: Other

Investigational Product Name: GOSERELIN
Active Substance: GOSERELIN ACETATE
Modality: Peptide/protein/enzyme
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: Authorised (SCP111850463 record present)
Maximum Dose: 3.6 mg (maxDailyDoseAmount)

Investigational Product Name: LEUPRORELIN
Active Substance: LEUPRORELIN ACETATE
Modality: Peptide/protein/enzyme
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: Authorised (SCP151923 record present)
Maximum Dose: 3.75 mg (maxDailyDoseAmount)

Investigational Product Name: TRIPTORELIN
Active Substance: TRIPTORELIN ACETATE
Modality: Peptide/protein/enzyme
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: Authorised (SCP1035124 record present)
Maximum Dose: 3.75 mg (maxDailyDoseAmount)

Investigational Product Name: DEXAMETHASONE
Active Substance: BETAMETHASONE SODIUM PHOSPHATE
Modality: Small molecule
Routes Of Administration: BUCCAL USE
Route: BUCCAL USE
Authorisation Status: Used per routine clinical practice (SCP10332310 record)
Maximum Dose: 40 ml (maxDailyDoseAmount as provided)

Combination Treatment: Yes

Related trials

Other published trials that may interest you.