Clinical trial • Phase III • Oncology

CAMIZESTRANT for Advanced breast cancer

Phase III trial of CAMIZESTRANT for Advanced breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced breast cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-06-2024
First CTIS Authorization Date
30-09-2024

Trial design

Randomised, open-label, physician's choice cdk4/6 inhibitor plus endocrine therapy (comparator options listed include palbociclib [ibrance 75 mg/100 mg/125 mg film-coated tablets], ribociclib [ribociclib], abemaciclib [verzenios 50/100/150 mg film-coated tablets]) combined with endocrine therapies (letrozole, anastrozole, exemestane, or fulvestrant). specific product names included in the dossier: ibrance 75/100/125 mg film-coated tablets; verzenios 50/100/150 mg film-coated tablets; ribociclib; exemestane; letrozole; fulvestrant. dosing schedules not specified in the public record.-controlled Phase III trial in Czechia, Austria, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Physician's choice CDK4/6 inhibitor plus endocrine therapy (comparator options listed include palbociclib [IBRANCE 75 mg/100 mg/125 mg film-coated tablets], ribociclib [RIBOCICLIB], abemaciclib [Verzenios 50/100/150 mg film-coated tablets]) combined with endocrine therapies (letrozole, anastrozole, exemestane, or fulvestrant). Specific product names included in the dossier: IBRANCE 75/100/125 mg film-coated tablets; Verzenios 50/100/150 mg film-coated tablets; RIBOCICLIB; EXEMESTANE; LETROZOLE; FULVESTRANT. Dosing schedules not specified in the public record.
Biomarker Stratified
True, BRCA1 | BRCA2 | PALB2
Target Sample Size
364

Eligibility

Recruits 364 adults.

Inclusion criteria

  • {"criterion_text":"- Adult females, pre/peri-menopausal and/or postmenopausal, and adult males\n- Histologically or cytologically documented diagnosis of HRpositive, HER2-negative breast cancer\n- Advanced breast cancer with either locally Advanced disease not amenable to curative treatment or metastatic disease\n- ECOG performance status of O or 1 with no deterioration over the previous two weeks\n- FFPE tissue from each participant (written confirmation of the availability can meet the study requirement for randomization) - Documented loss of function mutation in BRCA1, BRCA2,or PALB2, adhering to the following criteria a) Positive pre-existing local germline or tumour tissue result from an accredited laboratory appoved by theSponsor (CAP/CLIA, ISO15189 or equivalent); OR b) Positive result from prospective tumour tissue test performed at a central laboratory\n- Adequate organ and marrow function"}

Exclusion criteria

  • {"criterion_text":"- Participants with history of MDS/AML or with features suggestive of MDS/AML\n- Participants with any known predisposition to bleeding\n- Active tuberculosis infection\n- Cardiac criteria, including history of arrythmia and cardiovascular disease\n- Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions.\n- Major surgical procedure or significant traumatic injury within 4weeks of the first dose of study intervention oran anticipated need for major surgery during the study\n- Palliative radiotherapy with a limited field of radiation within 2weeks or with wide field of radiation orto more than 30% of the bone marrow within 4 weeks before the first dose of study treatment\n- Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation\n- Prior treatment within 28 days with blood product support or growth factor support\n- Any systemic concurrent anti-cancer treatment\n- Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation: (a) Strong and moderate CYP3A4 inducers/inhibitors(b )Sensitive CYP2B6 substrates(c)Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.\n- The following exclusion criteria apply to treatments administered for early breast cancer: (a)Disease progression s 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy (b)Disease progression </= 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer (c)Disease progression </= 1 year (365 days) from the last dose with aCDK4/6i in the adjuvant setting (d)Disease progression :s; 1 year (365 days) from the last dose of an oral SERD including camizestrant.\n- Any history of persisting severe cytopenia\n- Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections\n- Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection\n- History of another primary malignancy\n- Persistent toxicities (CTCAE Grade ~ 2) caused by previous anti-cancer therapy excluding alopecia\n- Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease\n- Evidence of active and uncontrolled hepatitis B and/or hepatitis C\n- Evidence of active and uncontrolled HIV infection\n- Concomitant use of drugs that are known to prolong QT and have a known risk of TdP\n- Systemic use of atropine"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival defined as time from randomisation until progression per RECIST vl.1 as assessed by BICR, or death due to any cause.","definition_or_measurement_approach":"Progression-Free Survival defined as time from randomisation until progression per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival defined as the time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"Time from randomisation until date of death due to any cause."}
  • {"endpoint_text":"- Progression Free Survival 2 defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.","definition_or_measurement_approach":"Time from randomisation to the earliest of the progression event following initial investigator-assessed progression, after first subsequent therapy, or death."}
  • {"endpoint_text":"- Time to chemotherapy defined as time from randomisation until the start date of the first subsequent chemotherapy treatment after discontinuation of randomised treatment (censoring participants who died prior to initiation of chemotherapy).","definition_or_measurement_approach":"Time from randomisation until start date of first subsequent chemotherapy after discontinuation of randomised treatment (participants dying prior to chemotherapy initiation are censored)."}
  • {"endpoint_text":"- Objective Response Rate defined as the proportion of participants who have a complete or partial response, as determined by BICR per RECIST vl.1.","definition_or_measurement_approach":"Proportion of participants with complete response (CR) or partial response (PR) per BICR using RECIST v1.1."}
  • {"endpoint_text":"- Duration of Response defined as the time from the date of first documented response until date of documented progression per RECIST vl.1 as assessed by BICR, or death due to any cause.","definition_or_measurement_approach":"Time from date of first documented response to date of documented progression per RECIST v1.1 as assessed by BICR, or death."}
  • {"endpoint_text":"- Participant-reported tolerability defined as proportion of all dosed participants reporting different levels of severity of diarrhoea as measured by the diarrhoea single item (EORTCIL237 /IL239/IL240) and different levels of severity of abdominal pain as measured by the abdominal pain single item (EORTCIL237 /IL239/IL240).","definition_or_measurement_approach":"Proportion of dosed participants reporting severity levels for diarrhoea and abdominal pain measured by single-item EORTC instruments (IL237/IL239/IL240)."}
  • {"endpoint_text":"- Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).","definition_or_measurement_approach":"Time to deterioration in patient-reported global health status/quality of life measured using EORTC QLQ global health status/QoL scale."}
  • {"endpoint_text":"- Change from baseline in patient-reported global health status/Qol as measured by the global health status/Qol scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)","definition_or_measurement_approach":"Change from baseline in patient-reported global health status/QoL using EORTC QLQ global health status/QoL scale."}
  • {"endpoint_text":"- Plasma concentrations of saruparib (AZD5305)","definition_or_measurement_approach":"Measurement of plasma concentrations of saruparib (AZD5305) (pharmacokinetic sampling)."}
  • {"endpoint_text":"- Plasma concentrations of camizestrant","definition_or_measurement_approach":"Measurement of plasma concentrations of camizestrant (pharmacokinetic sampling)."}
  • {"endpoint_text":"- Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.","definition_or_measurement_approach":"Analysis of samples to develop companion diagnostics; performance characteristics compared for consistency with clinical trial enrolment assays."}

Recruitment

Planned Sample Size
364
Recruitment Window Months
69
Consent Approach
Informed consent is obtained from adult participants. Subject information and informed consent form (SIS and ICF) documents are provided (Main ICF and multiple addenda/options: Biomarker, Genetic, Optional Genetics, Pregnant Partner, Future Research), with language-specific versions listed in the study documents (examples include English, German, Polish, Italian, French, Portuguese, Bulgarian, Czech, Hungarian). No assent procedure for minors is described (study enrols adults).

Geography

Total Number Of Sites
83
Total Number Of Participants
136

Czechia

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
03-10-2024
Processing Time Days
20
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
University Hospital Olomouc
Department Name
Oncology clinic
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Clinic of radiology and oncology
Contact Person Name
Adam Paulik
Contact Person Email
adam.paulik@fnhk.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Department of clinical oncology
Contact Person Name
Milos Holanek
Contact Person Email
holanek@mou.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Oncology department
Contact Person Name
Petra Holeckova
Contact Person Email
petra.holeckova@bulovka.cz
Site Name
Multiscan s.r.o.
Department Name
Oncology department
Contact Person Name
Martin Smakal
Contact Person Email
msmakal@gmail.com
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Oncology clinic
Contact Person Name
Zuzana Bielcikova
Contact Person Email
zuzana.bielcikova@vfn.cz

Austria

Earliest CTIS Part Ii Submission Date
25-07-2024
Latest Decision Or Authorization Date
31-10-2024
Processing Time Days
98
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Medical University Of Vienna
Department Name
Universitätsklinik f. Innere Medizin I
Contact Person Name
Maximilian Marhold
Site Name
Ordensklinikum Linz GmbH
Department Name
Interne I: Medizinische Onkologie und Haematologie
Contact Person Name
Renate Pusch
Contact Person Email
renate.pusch@ordensklinkum.at
Site Name
Medical University Of Graz
Department Name
Clinical Division for Oncology
Contact Person Name
Christoph Suppan
Contact Person Email
christoph.suppan@medunigraz.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
University Clinic for Gynaecology and Obstetrics
Contact Person Name
Daniel Egle
Contact Person Email
daniel.egle@tirol-kliniken.at

France

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
19
Number Of Sites
11
Number Of Participants
16

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Mario Campone
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Contact Person Name
Paule Augereau
Site Name
CHU Besancon
Department Name
medical oncology
Contact Person Name
Elsa Curtit
Contact Person Email
ecurtit@chu-besancon.fr
Site Name
Centre Henri Becquerel
Department Name
Medical Oncology
Contact Person Name
Jean-Christophe Thery
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Audrey Mailliez
Contact Person Email
a-mailliez@o-lambret.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology and Hematology
Contact Person Name
Elie Rassy
Contact Person Email
elie.el-rassy@gustaveroussy.fr
Site Name
Institut Curie
Department Name
Oncology
Contact Person Name
Delphine Loirat
Contact Person Email
delphine.loirat@curie.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Thomas Bachelot
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Contact Person Name
Florence Dalenc
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Contact Person Name
Alexandre Tassin de Nonneville
Contact Person Email
denonnevillea@ipc.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest (Angers address)
Department Name
Oncology
Contact Person Name
Paule Augereau

Poland

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
27
Number Of Sites
10
Number Of Participants
13

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Chemioterapii
Contact Person Name
Rodryg Ramlau
Contact Person Email
rramlau@gmail.com
Site Name
Centrum Medyczne Hcp Sp. z o.o.
Department Name
Ośrodek Badań Klinicznych
Contact Person Name
Robert Kobylarek
Contact Person Email
robert.kobylarek@cmhcp.pl
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Maria Pawłowicz
Contact Person Email
maria.pawlowicz@szpitalbp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
zbigniew.nowecki@nio.gov.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
I Oddził Onkologii Klinicznej z Chemioterapia Dzienna
Contact Person Name
Anna Dobrzynska-Rutkowska
Contact Person Email
cozl@cozl.eu
Site Name
Kliniki Neuroradiochirurgii Sp. z o.o.
Department Name
Kliniczny Oddzial Chemioterapii
Contact Person Name
Tadeusz Pienkowski
Contact Person Email
t.pienkowski@onkologiaradom.pl
Site Name
Centrum Medyczne Hcp (additional site)
Department Name
Ośrodek Badań Klinicznych
Contact Person Name
Robert Kobylarek
Contact Person Email
robert.kobylarek@cmhcp.pl
Site Name
Narodowy Instytut Onkologii (additional)
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
zbigniew.nowecki@nio.gov.pl

Germany

Earliest CTIS Part Ii Submission Date
04-09-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
27
Number Of Sites
14
Number Of Participants
22

Sites

Site Name
Staedtisches Klinikum Dessau
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Hermann Voss
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Zentrum für Tumorerkrankungen (NCT)
Contact Person Name
Andreas Schneeweiss
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Gynäkologie und Geburtsmedizin
Contact Person Name
Brigitte Sophia Winkler
Contact Person Email
bwinkler@ukaachen.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinikum rechts der Isar der TU München
Contact Person Name
Evelyn Klein
Contact Person Email
evelyn.klein@mri.tum.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Brustzentrum
Contact Person Name
Michael Untch
Site Name
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Claudia Haenle
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Contact Person Name
Peter Fasching
Site Name
Universitaet Leipzig
Department Name
Clinic and Policlinic for Gynaeocology
Contact Person Name
Bahriye Aktas
Site Name
Haematologie-Onkologie im Zentrum MVZ GmbH
Department Name
Hämatologie-Onkologie Im Zentrum MVZ GmbH
Contact Person Name
Bernhard Jürgen Heinrich
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Frauenklinik
Contact Person Name
Eugen Ruckhäberle
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Universitätskrankenhaus Münster
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Tjoung-Won Park-Simon
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Svenja Wulf
Site Name
Mammazentrum Hamburg MVZ GbR
Contact Person Name
Christian Schem
Contact Person Email
schem@mammazentrum.eu

Hungary

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
21
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
Semmelweis Egyetem
Department Name
Belgyógyászati és Onkológiai Klinika
Contact Person Name
Gyöngyvér Szentmártoni
Contact Person Email
gyszentmartoni@gmail.com
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Onkológiai Osztály
Contact Person Name
Károly Máhr
Contact Person Email
mahrkaroly1967@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Oncology
Contact Person Name
Balázs Madaras
Contact Person Email
studymadaras@oncol.hu
Site Name
University Of Debrecen
Department Name
Oncology
Contact Person Name
Péter Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Oncology
Contact Person Name
Mátyás Bíró
Contact Person Email
dr.matyas.biro@gmail.com
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Oncology
Contact Person Name
Edina Mészáros
Contact Person Email
m.edina@uzsoki.hu
Site Name
Semmelweis Egyetem (additional site)
Department Name
Belgyógyászati és Onkológiai Klinika
Contact Person Name
Gyöngyvér Szentmártoni
Contact Person Email
gyszentmartoni@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
103
Number Of Sites
12
Number Of Participants
22

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Agostina Stradella
Contact Person Email
astradella@iconcologia.net
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Jose Juan Illarramendi Manas
Site Name
Hospital San Pedro De Alcantara
Department Name
Oncology
Contact Person Name
Santiago Gonzalez Santiago
Contact Person Email
santigsanti@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Javier Pascual López
Contact Person Email
javier.pascual@ibima.eu
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Maria Teresa Martinez
Contact Person Email
maitemartinez3@yahoo.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Manuel Ruiz Borrego
Contact Person Email
ruizsabater@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Laura Lema Roso
Contact Person Email
laura.lema@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Contact Person Name
Maria Isabel Blancas Lopez-Barajas
Contact Person Email
isabelblancas@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Isabel Pimentel
Contact Person Email
ipimentel@vhio.net
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Jose Angel Garcia Saenz
Contact Person Email
jgsaenz@salud.madrid.org
Site Name
Hospital San Pedro De Alcantara (duplicate entry)
Department Name
Oncology
Contact Person Name
Santiago Gonzalez Santiago
Contact Person Email
santigsanti@gmail.com
Site Name
Institut Catala D'oncologia (additional address)
Department Name
Oncology
Contact Person Name
Agostina Stradella
Contact Person Email
astradella@iconcologia.net

Italy

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
02-10-2024
Processing Time Days
104
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology 2
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Medical Senology
Contact Person Name
Marco Angelo Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Medical Ongolory at Ongolofica Medica Provinciale
Contact Person Name
Laura Cortesi
Contact Person Email
laura.cortesi@ausl.re.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncology Disivion
Contact Person Name
Michelino De Laurentiis
Site Name
Humanitas Mirasole S.p.A.
Department Name
Breast Oncology Unit
Contact Person Name
Carmen Criscitiello
Contact Person Email
carmen.criscitiello@hunimed.eu
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Precision Medicine in Senology
Contact Person Name
Alessandra Fabi
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Onco Ematology at SC Ongologia
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it

Bulgaria

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
03-10-2024
Processing Time Days
20
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Department of Medical Oncology
Contact Person Name
Kremena Vasileva
Contact Person Email
Kre.ivanova@abv.bg
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
Department of Medical Oncology and Oncological Diseases in Gastroenterology
Contact Person Name
Antoaneta Tomova
Contact Person Email
dr.tomova@gmail.com
Site Name
Complex Oncology Center Stara Zagora Ltd.
Department Name
Department of Medical Oncology
Contact Person Name
Tatyana Todorova-Andreeva
Contact Person Email
dr.tatyana.andreeva@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
12
Number Of Sites
7
Number Of Participants
11

Sites

Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Isália Miguel
Contact Person Email
imiguel@ipolisboa.min-saude.pt
Site Name
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Department Name
Medical Oncology
Contact Person Name
Daniela Azevedo
Contact Person Email
dazevedo@chtmad.min-saude.pt
Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Gabriela Sousa
Contact Person Email
3036@ipocoimbra.min-saude.pt
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Medical Oncology
Contact Person Name
Sofia Braga
Contact Person Email
sofia.braga@cuf.pt
Site Name
Hospital Lusiadas Porto
Department Name
Medical Oncology
Contact Person Name
Ana Ferreira
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Medical Oncology
Contact Person Name
Alexandra Mesquita
Site Name
Instituto Portugues De Oncologia De Lisboa (additional)
Department Name
Medical Oncology
Contact Person Name
Isália Miguel
Contact Person Email
imiguel@ipolisboa.min-saude.pt

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
IQVIA Limited
Name
Fortrea Inc.
Name
Labcorp Early Development Laboratories Inc.
Responsibilities
Central lab
Name
Covance Bioanalytical Services LLC
Responsibilities
Central lab bioanalitics

Third parties

  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"recruitment support","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Baseline ctDNA, Non-baseline ctDNA, Blood for CHIP will be tested","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Yourgene Genomic Services Limited","duties_or_roles":"optional Gx sample will be send from site to labcorp, but tested with this vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"Statistical analysis and reporting","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Central lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Clinical supply","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IRT","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Covance Bioanalytical Services LLC","duties_or_roles":"Central lab bioanalitics","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad Genetics Inc.","duties_or_roles":"Biomarker tumor testing (BRCA1/2, PALB2), germline testing and CDx development, tumor progression testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc. (duplicate entry for samples)","duties_or_roles":"biopharma_samples@guardanthealth.com (sample testing duties noted)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Camizestrant
Active Substance
CAMIZESTRANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Saruparib
Active Substance
SARUPARIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Combination Treatment
Yes

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