Clinical trial • Phase III • Oncology
OLAPARIB for BRCA-mutated advanced ovarian cancer (FIGO stage III-IV)
Phase III trial of OLAPARIB for BRCA-mutated advanced ovarian cancer (FIGO stage III-IV).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- BRCA-mutated advanced ovarian cancer (FIGO stage III-IV)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 09-02-2024
- First CTIS Authorization Date
- 15-03-2024
Trial design
Randomised, placebo - film-coated tablets (control arm); dose/schedule not specified Phase III trial across 25 sites in Netherlands, Italy, Poland and others.
- Randomised
- Yes
- Comparator
- Placebo - film-coated tablets (control arm); dose/schedule not specified
- Target Sample Size
- 222
Eligibility
Recruits 222 adults.
Inclusion criteria
- {"criterion_text":"- PRINCIPAL INCLUSION CRITERIA (most important listed). Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III – IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal)."}
- {"criterion_text":"- Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery."}
- {"criterion_text":"- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)."}
- {"criterion_text":"- Patients who have completed first line platinum (eg. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation: • Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study."}
Exclusion criteria
- {"criterion_text":"- PRINCIPAL EXCLUSION CRITERIA (the most important are listed). BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. \"Variants of uncertain clinical significance\" or \"Variant of unknown significance\" or \"Variant, favour polymorphism\" or \"benign polymorphism\" etc)."}
- {"criterion_text":"- Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)"}
- {"criterion_text":"- Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment."}
- {"criterion_text":"- Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible)."}
- {"criterion_text":"- Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer."}
- {"criterion_text":"- Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease)."}
- {"criterion_text":"- Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS) by investigator review of RECIST data","definition_or_measurement_approach":"Investigator-assessed progression-free survival according to modified RECIST 1.1 (investigator review of RECIST data)."}
Secondary endpoints
- {"endpoint_text":"- Efficacy in patients following First Line Platinum Based Chemotherapy by assessment of: a) overall survival b) time to earliest progression by RECIST or Cancer Antigen-125 (CA- 125) c) time from randomisation to second progression.","definition_or_measurement_approach":"Overall survival; time to earliest progression assessed by RECIST or CA-125; time from randomisation to second progression (PFS2)."}
- {"endpoint_text":"- The Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) will be used to determine: a) Change from baseline in TOI score b) Proportion improved","definition_or_measurement_approach":"Health-related quality of life assessed using the TOI of FACT-O: change from baseline in TOI score and proportion of patients improved."}
- {"endpoint_text":"- Development and delivery of a BRCA mutation companion diagnostic","definition_or_measurement_approach":"Development and delivery of a BRCA mutation companion diagnostic (no further measurement details provided)."}
- {"endpoint_text":"- Adverse events, physical examination, vital signs including blood pressure, pulse, electrocardiogram and laboratory findings including clinical chemistry and haematology","definition_or_measurement_approach":"Safety assessments including AEs, physical exams, vital signs, ECG and laboratory tests (clinical chemistry and haematology)."}
- {"endpoint_text":"- Efficacy of olaparib by time to first subsequent therapy or death (TFST).","definition_or_measurement_approach":"Time from randomisation to first subsequent anti-cancer therapy or death (TFST)."}
- {"endpoint_text":"- Efficacy of olaparib by time to second subsequent therapy or death (TSST).","definition_or_measurement_approach":"Time from randomisation to second subsequent anti-cancer therapy or death (TSST)."}
- {"endpoint_text":"- Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT).","definition_or_measurement_approach":"Time from randomisation to study treatment discontinuation or death (TDT)."}
Recruitment
- Planned Sample Size
- 222
- Recruitment Window Months
- 67
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent form (ICF) documents for adults are listed (languages include Italian, Polish, Spanish, French and English). No assent or minor consent procedures are described in the materials provided.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 88
Netherlands
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 19-08-2025
- Processing Time Days
- 543
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- Gabe Sonke
- Contact Person Email
- g.sonke@nki.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 19-09-2025
- Processing Time Days
- 574
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Medical Oncology Gynecology
- Contact Person Name
- Vanda Salutari
- Contact Person Email
- vanda.salutari@policlinicogemelli.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Medical Oncology Gynecology
- Contact Person Name
- Nicoletta Colombo
- Contact Person Email
- nicoletta.colombo@ieo
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Gynecological Surgery
- Contact Person Name
- Francesco Raspagliesi
- Contact Person Email
- raspagliesi@istitutotumori.mi.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Medical Oncology
- Contact Person Name
- Valentina Guarnieri
- Contact Person Email
- valentina.guarneri@iov.veneto.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Medical Oncology
- Contact Person Name
- Paola Malaguti
- Contact Person Email
- paola.malaguti@ifo.it
Poland
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 25-08-2025
- Processing Time Days
- 549
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddział Kliniczny Onkologii i Immunoonkologii z Osrodkiem Dziennym Terapii Onkologicznej
- Contact Person Name
- Monika Kotyla
- Contact Person Email
- mkotyla@wp.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Olsztynie
- Department Name
- Oddzial Ginekologii Onkologicznej
- Contact Person Name
- Magdalena Sikorska
- Contact Person Email
- megiann@wp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Contact Person Name
- Mariusz Bidzinski
- Contact Person Email
- bidzinski.m@gmail.com
- Site Name
- Niepubliczny Zakład Opieki Zdrowotnej Innowacyjna Medycyna
- Contact Person Name
- Tomasz Byrski
- Contact Person Email
- tbyrski@pum.edu.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 724
- Number Of Sites
- 8
- Number Of Participants
- 18
Sites
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncología Médica
- Contact Person Name
- Raúl Márquez Vázquez
- Contact Person Email
- raulmarquez@mdanderson.es
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Oncología Médica
- Contact Person Name
- Mª Jesús Rubio Pérez
- Contact Person Email
- mjruper@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Médica
- Contact Person Name
- Lorena Fariñas Madrid
- Contact Person Email
- lfarinas@vhio.net
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncología Médica
- Contact Person Name
- Andrés Ruipérez
- Contact Person Email
- andres.cervantes@uv.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología Médica
- Contact Person Name
- Beatriz Pardo Búrdalo
- Contact Person Email
- bpardo@iconcologia.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncología Médica
- Contact Person Name
- Andrés Redondo Sánchez
- Contact Person Email
- aredondo12@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncología Médica
- Contact Person Name
- Ignacio Romero Noguera
- Contact Person Email
- iromero@fivo.org
- Site Name
- Hospital Universitario La Paz (additional listed site details duplicated in source)
- Department Name
- Oncología Médica
- Contact Person Name
- Andrés Redondo Sánchez
- Contact Person Email
- aredondo12@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 803
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Medical Oncology
- Contact Person Name
- Yolanda Fernandez
- Contact Person Email
- y.fernandez@nancy.unicancer.fr
- Site Name
- L'Hopital Prive Du Confluent
- Department Name
- Medical Oncology
- Contact Person Name
- Cyriac BLONZ
- Contact Person Email
- cblonz@vivalto-sante.com
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Contact Person Name
- Alexandra Leary
- Contact Person Email
- alexandra.leary@gustaveroussy.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Medical Oncology
- Contact Person Name
- Laurence Gladieff
- Contact Person Email
- gladieff.laurence@iuct-oncopole.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Coriolan Lebreton
- Contact Person Email
- c.lebreton@bordeaux.unicancer.fr
- Site Name
- Hopital Tenon
- Department Name
- Medical Oncology
- Contact Person Name
- Jean-Pierre Lotz
- Contact Person Email
- jean-pierre.lotz@aphp.fr
- Site Name
- L'Hopital Prive Du Confluent (duplicate entry in source list)
- Department Name
- Medical Oncology
- Contact Person Name
- Cyriac BLONZ
- Contact Person Email
- cblonz@vivalto-sante.com
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Lynparza 100 mg film-coated tablets
- Active Substance
- OLAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised (EU marketing authorisation PRD6163466, marketingAuthNumber EU/1/14/959/003)
- Dose Levels
- 100 mg
- Maximum Dose
- 600 mg
- Investigational Product Name
- Lynparza 150 mg film-coated tablets
- Active Substance
- OLAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised (EU marketing authorisation PRD6152224, marketingAuthNumber EU/1/14/959/004)
- Dose Levels
- 150 mg
- Maximum Dose
- 600 mg
- Investigational Product Name
- Placebo - film-coated tablets
- Modality
- Other
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