Clinical trial • Phase III • Oncology

Sacituzumab govitecan for Endometrial cancer (recurrent or persistent)

Phase III trial of Sacituzumab govitecan for Endometrial cancer (recurrent or persistent).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Endometrial cancer (recurrent or persistent)
Trial Stage
Phase III
Drug Modality
ADC | Small molecule

Key dates

Initial CTIS Submission Date
16-08-2024
First CTIS Authorization Date
09-12-2024

Trial design

Randomised, open-label, treatment of physician's choice (tpc): doxorubicin (doxorubicin teva 2 mg/ml concentrate for solution for infusion; intravenous per local label) or paclitaxel (intravenous, per local label). exact doses/schedules per locally approved product labels (not specified in ctis record).-controlled Phase III trial across 55 sites in France, Czechia, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of physician's choice (TPC): Doxorubicin (Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion; intravenous per local label) or Paclitaxel (intravenous, per local label). Exact doses/schedules per locally approved product labels (not specified in CTIS record).
Target Sample Size
461

Eligibility

Recruits 461 No vulnerable populations selected. Trial enrols adult participants (participants assigned female at birth, 18 years or older or minimum age per country) who must be able to understand and give written informed consent. No assent procedures described..

Pregnancy Exclusion
Have a positive serum pregnancy test at screening or enrollment or have plans to breastfeed during the study period and for 1 month following the last dose of study intervention.
Vulnerable Population
No vulnerable populations selected. Trial enrols adult participants (participants assigned female at birth, 18 years or older or minimum age per country) who must be able to understand and give written informed consent. No assent procedures described.

Inclusion criteria

  • {"criterion_text":"-Willing and able to comply with the requirements and restrictions in this protocol."}
  • {"criterion_text":"-Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception(Section 11.5)."}
  • {"criterion_text":"-Life expectancy of ≥ 3 months"}
  • {"criterion_text":"-Participants assigned female at birth, 18 years of age or older (or minimum age according to country-specific requirements), and able to understand and give written informed consent."}
  • {"criterion_text":"-Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma)"}
  • {"criterion_text":"-Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately. - Neoadjuvant and/or adjuvant therapy is considered 1 prior line of systemic therapy. - Concurrent chemotherapy given during radiotherapy with radio-sensitizing intent (eg, cisplatin during external beam radiotherapy) will not be counted as a separate line of therapy. However, if systemic chemotherapy is given before or after radiotherapy, this would be considered as a separate line of therapy. - Prior monoclonal antibodies or targeted therapies, including but not limited to bevacizumab, poly (adenosine diphosphate-ribose) polymerase inhibitors (PARPis), trastuzumab, will count as a line of treatment if given as a single agent with the intent of controlling disease. If these agents are given in combination with chemotherapy and continued as maintenance monotherapy, they will not be counted as a separate line of treatment. Additionally, maintenance therapy with a PARPi or selinexor will not be counted as a separate line of therapy. - There is no restriction regarding prior hormonal or hormonal-based therapy. Hormonal or hormonal-based therapy does not count as a line of therapy. However, if hormonal therapy is combined with a targeted agent (eg, mammalian target of rapamycin [mTOR] inhibitor [everolimus] or cyclin-dependent kinase [CDK]4/6 inhibitor), this would count as a separate line of therapy. - For participants who are ineligible for anti-PD-1/PD-L1 therapy due to medical comorbidities, or if anti-PD-1/PD-L1 agents are not available as standard-of-care therapy in any line of treatment according to local standards, prior treatment with an anti-PD-1/PD-L1 agent is not required."}
  • {"criterion_text":"-Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator. Participants must not have any contraindications to receive treatment with doxorubicin or paclitaxel as per the locally approved product label."}
  • {"criterion_text":"-Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria by investigator assessment. - If a participant has disease based on pleural effusion or ascites alone (with no other radiologically evaluable lesions), this must be cytologically confirmed. - Participants who require drainage of a fluid-based nontarget lesion (eg, paracentesis or thoracentesis) every 8 weeks or more frequently, are not eligible."}
  • {"criterion_text":"-Documented disease progression by CT or MRI during or after the most recent therapy per RECIST v1.1 criteria by investigator assessment."}
  • {"criterion_text":"-Availability of tumor tissue from an archival or fresh biopsy for assessment of Trop-2 and other study biomarkers. Tissue submission should be in the form of a formalin-fixed paraffin-embedded block (preferably) or ≥ 20 freshly sectioned, unstained slides. Tissue must be submitted within 4 weeks of randomization. - If archival tumor tissue is available, it should preferably be from the most recently available tumor biopsy (obtained ideally within 12 months prior to randomization), from a locally recurrent or metastatic site. If archival tissue is not available, a fresh biopsy, preferably from a locally recurrent or metastatic site should be performed before randomization. Aspirate samples (eg, fine needle aspirates, endometrial aspirates), bone biopsies, and cytology samples are not suitable samples. If < 20 unstained slides are available, and it is not clinically feasible to obtain a new biopsy, the participant may still be eligible upon consultation with the sponsor medical monitor."}
  • {"criterion_text":"-Eastern Cooperative Oncology Group PS of 0 or 1 (see Appendix 11.7)."}

Exclusion criteria

  • {"criterion_text":"-Need for ongoing systemic anticancer therapies aside from the study treatment."}
  • {"criterion_text":"-Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In participants with a history of HBV or HCV, participants with detectable viral loads will be excluded. 10.1 Participants who test positive for hepatitis B surface antigen are excluded. Participants who test positive for hepatitis B core antibody will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. 10.2 Participants who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Participants with a known history of HCV or a positive HCV antibody test will not require an HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease."}
  • {"criterion_text":"-Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded."}
  • {"criterion_text":"-Scheduled surgery during the study, other than a minor surgery that would not delay study treatment."}
  • {"criterion_text":"-Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6 months prior to randomization."}
  • {"criterion_text":"-Have a positive serum pregnancy test at screening or enrollment or have plans to breastfeed during the study period and for 1 month following the last dose of study intervention."}
  • {"criterion_text":"-Use of any live vaccine against infectious diseases within 30 days of the first dose of study drug."}
  • {"criterion_text":"-Have other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations."}
  • {"criterion_text":"-Any medical condition that, in the investigator’s or sponsor’s opinion, poses an undue risk to the participant’s participation in the study."}
  • {"criterion_text":"-Participants who are candidates for curative-intent therapy at the time of study enrollment."}
  • {"criterion_text":"-Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator."}
  • {"criterion_text":"-Known or severe (Grade 3 or higher) hypersensitivity to SG and/or the chemotherapy regimen of choice in the TPC group (eg doxorubicin or paclitaxel), their metabolites, or formulation excipients."}
  • {"criterion_text":"-Received any prior treatment with a Trop-2-directed ADC."}
  • {"criterion_text":"-Received any prior treatment (including an ADC) containing a chemotherapeutic agent targeting topoisomerase I."}
  • {"criterion_text":"-Have had a prior anticancer biologic agent within 4 weeks prior to the first dose of study drug or have had prior chemotherapy, targeted small molecule therapy, hormonal or hormonal-based therapy, or radiation therapy within 2 weeks prior to the first dose of study drug."}
  • {"criterion_text":"-Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.Note: Use of investigational anti-PD-1/PD-L1 agents are acceptable if the last dose was longer than 28 days prior to first dose of study drug."}
  • {"criterion_text":"-Have not recovered (ie, Grade 2 or higher is considered not recovered) from AEs due to a previously administered agent. Participants with Grade 2 or lower neuropathy or any grade alopecia are an exception to this criterion and will qualify for the study. Participants with immune-mediated endocrine AEs Grade 2 or lower requiring treatment or hormone replacement are eligible. If participants underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Participants who underwent major surgery within 3 weeks of randomization are not eligible."}
  • {"criterion_text":"-Requirement for ongoing therapy with any prohibited medications listed in Section 5.6.2."}
  • {"criterion_text":"-Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for ≥ 4 weeks prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg/day or less of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability."}
  • {"criterion_text":"-Have an active second malignancy. 5.1 Participants with a history of malignancy that have been completely treated, with noevidence of active cancer for 3 years prior to randomization, or participants with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll."}
  • {"criterion_text":"-Left ventricular ejection fraction < 50% on screening echocardiogram or multigated acquisition (scan)."}
  • {"criterion_text":"-Have a history of significant cardiovascular disease, defined as: 7.1 Myocardial infarction or unstable angina pectoris within 6 months of randomization. 7.2 History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. 7.3 New York Heart Association Class III or greater congestive heart failure."}
  • {"criterion_text":"-Have an active serious infection requiring systemic antimicrobial therapy."}
  • {"criterion_text":"-Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody at screening) with detectable viral load. HIV testing is not required and can be done if clinically indicated and per local standard of care."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-PFS, defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per RECIST v1.1, or death from any cause, whichever comes first","definition_or_measurement_approach":"Progression-free survival assessed by blinded independent central review (BICR) per RECIST v1.1; time from randomization to objective PD by BICR or death."}
  • {"endpoint_text":"-OS, defined as the time from the date of randomization until death due to any cause","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"-ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1","definition_or_measurement_approach":"Objective response rate measured by BICR per RECIST v1.1; CR or PR confirmed ≥4 weeks after initial documentation."}
  • {"endpoint_text":"-Change from baseline in the physical functioning domain of the European Organisation for Research and Treatment of Cancer quality of life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 16","definition_or_measurement_approach":"Change from baseline to Week 16 in the EORTC QLQ-C30 physical functioning domain score."}
  • {"endpoint_text":"-PFS, defined as the time from the date of randomization until the date ofobjective PD, as assessed by investigator per RECIST v1.1, or death from any cause, whichever comes first","definition_or_measurement_approach":"Investigator-assessed progression-free survival per RECIST v1.1; time from randomization to objective PD by investigator or death."}
  • {"endpoint_text":"-ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1","definition_or_measurement_approach":"Objective response rate measured by investigator per RECIST v1.1; CR or PR confirmed ≥4 weeks after initial documentation."}
  • {"endpoint_text":"-DOR, defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD as assessed by BICR and investigator per RECIST v1.1, or death from any cause, whichever comes first","definition_or_measurement_approach":"Duration of response from first documented CR/PR to earlier of definitive PD (BICR or investigator) or death."}
  • {"endpoint_text":"-CBR, defined as the percentage of participants with best overall response of CR or PR that is confirmed ≥ 4 weeks after initial documentation of response or durable stable disease (SD; duration of SD ≥ 6 months from randomization to disease progression), as assessed by BICR and investigator perRECIST v1.1","definition_or_measurement_approach":"Clinical benefit rate = CR or PR confirmed ≥4 weeks after initial documentation or durable SD (SD ≥6 months); assessed by BICR and investigator per RECIST v1.1."}
  • {"endpoint_text":"-Incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities","definition_or_measurement_approach":"Safety: incidence and severity of TEAEs and clinically significant laboratory abnormalities collected during treatment and follow-up."}
  • {"endpoint_text":"-Change from baseline in GHS/QoL domain of the EORTC QLQ-C30 at Week 16","definition_or_measurement_approach":"Change from baseline to Week 16 in Global Health Status/Quality of Life domain of EORTC QLQ-C30."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
461
Recruitment Window Months
53
Consent Approach
Written informed consent is required from participants able to understand and provide consent (participants assigned female at birth, aged 18 or older or country-specific minimum age). Optional/auxiliary consents available (e.g., Optional PGx/genomic research ICF, Pregnancy follow-up ICF, FSR). Consent materials and patient-facing documents are provided in multiple language versions (English, French, Czech, Polish, Italian, German, Spanish, Greek and localised variants). No assent for minors is described (minors not eligible).

Methods

  • Physician referral letters (Physician Referral Letter) — site-to-patient referral channel described in recruitment materials; country-specific versions available (e.g., IT, CZ, PL, FR, ES, DE, GR).
  • Doctor-to-Patient letters — written communication from treating physicians to potential participants (country-specific versions).
  • Patient brochures (print and digital) — study information provided to potential participants in brochure form; digital patient brochures available.
  • Patient pre-enrollment information cards and patient post-enrollment information cards — concise printed materials for participants pre- and post-consent.
  • Patient study guides and flipcharts — printed/visual materials to explain study procedures to participants at sites.
  • ICF video scripts and ICF video storyboards — audiovisual materials to support informed consent (used as recruitment/information aids).
  • Digital patient study guide / digital recruitment materials and eCOA participant web backup quick reference guides — digital/remote materials to support recruitment and participant onboarding.
  • Patient comfort kits and associated notecards / supplies lists — supportive materials referenced in recruitment arrangements.

Geography

Total Number Of Sites
55
Total Number Of Participants
179

France

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
369
Number Of Sites
8
Number Of Participants
45

Sites

Site Name
Centre Antoine Lacassagne
Department Name
Oncologist
Contact Person Name
Philippe FOLLANA
Site Name
Centre Francois Baclesse
Department Name
Oncologie médicale
Contact Person Name
Florence JOLY LOBBEDEZ
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Oncologie médicale
Contact Person Name
Renaud SABATIER
Contact Person Email
sabatierr@ipc.unicancer.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncologie médicale
Contact Person Name
Marie-Christine KAMINSKY
Contact Person Email
mc.kaminsky@nancy.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Contact Person Name
Jean-Sébastien FRENEL
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Contact Person Name
Alexandra LEARY
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Contact Person Name
Jerome ALEXANDRE
Contact Person Email
jerome.alexandre@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncologie médicale
Contact Person Name
Benoit YOU
Contact Person Email
benoit.you@chu-lyon.fr

Czechia

Earliest CTIS Part Ii Submission Date
10-11-2024
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
359
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Jan Kummel
Contact Person Email
jan.kummel@fno.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynekologicko-porodnicka klinika
Contact Person Name
Michal Zikan
Contact Person Email
michal.zikan@bulovka.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Klinika gynekologie, porodnictví a neonatologie
Contact Person Name
David Cibula
Contact Person Email
David.Cibula@vfn.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Klinika gynekologie
Contact Person Name
Vojtech Tlusty
Contact Person Email
vojtech.tlusty@nnj.agel.cz

Poland

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
360
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej - Leczenie "Jednego Dnia"
Contact Person Name
Joanna Pikiel
Contact Person Email
joanna.pikiel@post.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Onkologii Klinicznej/Chemioterapii
Contact Person Name
Bozena Cybulska-Stopa
Contact Person Email
bozena.cybulska@dcopih.pl
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkoligii Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
lubomirbodnar.lb@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@usk.poznan.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Ginekologii, Położnictwa i Ginekologii Onkologicznej
Contact Person Name
Krzysztof Nowosielski
Contact Person Email
gabinet@drnowosielski.pl

Greece

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
343
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
General Hospital Of Messinia
Department Name
Oncology Department
Contact Person Name
Sofia Stamatopoulou
Contact Person Email
stamatopouloudoubali@yahoo.gr
Site Name
Areteio Hospital
Department Name
B’ Surgery clinic_Oncology unit
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
General Hospital Of Patras Agios Andreas
Department Name
Department of Internal Medicine_Division of Clinical Oncology_ Oncology Unit
Contact Person Name
Athina Christopoulou
Contact Person Email
athinachristo@hotmail.com
Site Name
Mitera S.A.
Department Name
Oncology Department
Contact Person Name
Ilias Athanasiadis
Contact Person Email
iathanasiadis@hygeia.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
377
Number Of Sites
13
Number Of Participants
67

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ginecologia Oncologica
Contact Person Name
Vanda Salutari
Site Name
Istituto Oncologico Veneto
Department Name
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Gynecology Oncology Department
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Ginecologica
Contact Person Name
Monika Ducceschi
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Dipartimento di Oncologia Medica, SOC di Oncologia Medica e Prevenzione Oncologica
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it
Site Name
Alessandro Manzoni Hospital
Department Name
Oncology
Contact Person Name
Federica Villa
Contact Person Email
fe.villa@asst-lecco.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Medical Oncology
Contact Person Name
Giorgio Valabrega
Contact Person Email
giorgio.valabrega@unito.it
Site Name
Careggi University Hospital
Department Name
Gynecological Medical Oncology
Contact Person Name
Maria Cristina Petrella
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Medical Oncology 1 University
Contact Person Name
Carmelo Bengala
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Alice Bergamini
Contact Person Email
bergamini.alice@hsr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Obstetrics and Gynecology Academic Unit n 2
Contact Person Name
Elisa Piovano
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology Division I
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Dipartimento di Oncologia
Contact Person Name
Alberto Farolfi
Contact Person Email
alberto.farolfi@irst.emr.it

Germany

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
431
Number Of Sites
9
Number Of Participants
11

Sites

Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Gynecology and Obstetrics
Contact Person Name
Holger Bronger
Contact Person Email
holger.bronger@tum.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Gynecology and Obstetrics
Contact Person Name
Sabine Heublein
Site Name
Universitat Heidelberg
Department Name
Gynecology and Obstetrics
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
Hochtaunus-Kliniken gGmbH
Department Name
Obstetrics and Gynaecology
Contact Person Name
Dominik Denschlag
Site Name
Universitaetsklinikum Essen AöR
Department Name
Gynecology and Obstetrics
Contact Person Name
Fabinshy Thangarajah
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Gynecology and Obstetrics
Contact Person Name
Tanja Fehm
Site Name
Universitaet Leipzig
Department Name
Gynaecology and Obstetrics, Gynaecologic Oncology
Contact Person Name
Bahriye Aktas
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Gynecology and Obstetrics
Contact Person Name
Linn Wölber
Contact Person Email
l.woelber@uke.de
Site Name
Medizinische Hochschule Hannover
Department Name
Obstetrics and Gynecology
Contact Person Name
Tjoung-Won Park-Simon

Spain

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
430
Number Of Sites
11
Number Of Participants
32

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncoogy
Contact Person Name
Lydia Gaba Garcia
Contact Person Email
lgaba@clinic.cat
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Contact Person Name
Cristina Churruca Galaz
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Maria Jose Bermejo Perez
Contact Person Email
cheberpe@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Onoclogy
Contact Person Name
Ana Santaballa Bertrán
Contact Person Email
santaballa_ana@gva.es
Site Name
Hospital Universitario De Jaen
Department Name
Oncology
Contact Person Name
Irene Martínez Martín
Contact Person Email
Irenemm225@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncoogy
Contact Person Name
Pablo Andreu Cobo
Contact Person Email
pandreuc@tauli.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Eva Maria Guerra Alia
Contact Person Email
eva_m_guerra@hotmail.com
Site Name
University Hospital Son Espases
Department Name
Oncology
Contact Person Name
Marina Justo de la Peña
Contact Person Email
marina.justo@ssib.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Sara Perez Ramirez
Contact Person Email
sperezramirez85@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Gloria Marquina
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Maria Quindos Varela
Contact Person Email
maria.quindos.varela@sergas.es

Sponsor

Primary sponsor

Full Name
Gilead Sciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
CRO services provided
Name
IQVIA RDS Hellas Single Member S.A.

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Not specified (sponsorDuties codes: 1,12,8)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"CRO services provided","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA provider","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Trodelvy 200 mg powder for concentrate for solution for infusion
Active Substance
Sacituzumab govitecan
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (EU/1/21/1592/001)
Frequency
Every 21 days
Investigational Product Name
Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion
Active Substance
Doxorubicin hydrochloride
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (PA 749/083/1)
Frequency
Every 21 days
Investigational Product Name
PACLITAXEL
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Frequency
Every 28 days

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