ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
NCT ID: NCT02855944
Last Updated: 2023-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
349 participants
INTERVENTIONAL
2017-03-01
2022-09-16
Brief Summary
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Detailed Description
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While PARP inhibitors have demonstrated consistent robust clinical activity in patients with relapsed ovarian cancer associated with HRD, prospective studies evaluating efficacy and safety of PARPi versus standard of care chemotherapy have been limited. The primary purpose of this Phase 3 study is to compare the efficacy and safety of rucaparib versus chemotherapy as treatment for relapsed ovarian cancer in patients with a deleterious BRCA1/2 mutation in their tumor.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rucaparib
Drug: Oral rucaparib
600 mg BID (twice a day)
Other Names:
* CO-338
* PF 01367338
* AG 14699
* Rubraca
Rucaparib
Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day
Chemotherapy
Monotherapy platinum (cisplatin or carboplatin) or platinum-based doublet chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, or cisplatin/gemcitabine administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
Single agent paclitaxel will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
Chemotherapy
Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
Interventions
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Chemotherapy
Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
Rucaparib
Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
* Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation
* Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Exclusion Criteria
* Prior treatment with any PARP inhibitor
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
* Women who are pregnant or breast feeding
* Hospitalization for bowel obstruction within 3 months prior to enrollment
18 Years
FEMALE
No
Sponsors
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Foundation Medicine
INDUSTRY
pharmaand GmbH
INDUSTRY
Responsible Party
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Locations
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Rocky Mountain Cancer Center
Denver, Colorado, United States
Augusta University
Augusta, Georgia, United States
Hospital Haroldo Juacaba Instituto do Cancer do Ceara
Fortaleza, Ceará, Brazil
Instituto de Oncologia do Parana (IOP)
Curitiba, Paraná, Brazil
União Brasileira de Educação e Assistência / Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CEPON-Centro de pesquisas Oncologicas
Florianópolis, Santa Catarina, Brazil
Hospital do Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto Nacional de Câncer Hospital do Câncer II
Rio de Janeiro, , Brazil
Hospital Pérola Byington - Centro de Referência da Saúde da Mulher
São Paulo, , Brazil
Hospital São Camilo
São Paulo, , Brazil
Tom Baker Cancer Center
Calgary, Alberta, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
CIUSSS de l'Estrie CHUS
Sherbrooke, Quebec, Canada
Masarykuv Onkologicky Ustav, Oddeleni komplexni klinicke onkologie
Brno, Jihormoravsky KRAJ, Czechia
Fakultni Nemocnice v Motole
Prague, Prague, Czechia
Fakultní Nemocnice Ostrava
Ostrava, , Czechia
Všeobecná Fakultní Nemocnice v Praze
Prague, , Czechia
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Carmel Medical Center
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Oncology Dept.
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo
Candiolo, , Italy
AO per l'emergenza Cannizzaro
Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, , Italy
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna Sp z o.o.
Grzybnica, West Pomeranian Voivodeship, Poland
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
Bialystok, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, , Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, , Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
Poznan, , Poland
Pomorska Akademia Medyczna w Szczecinie, Samodzielny Publiczny Szpital Kliniczny Nr 2
Szczecin, , Poland
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, , Russia
Kursk Regional Oncologic Dispensary
Kursk, , Russia
Moscow Clinical Scientific and Practical Center of Moscow Healthcare Department
Moscow, , Russia
Omsk Region Clinical Oncologic Dispensary
Omsk, , Russia
Pyatigorsk Oncological Dispensary
Pyatigorsk, , Russia
Ryazan Regional Clinical Oncology Dispensary
Ryazan, , Russia
Pavlov First Saint-Petersburg State Medical University
Saint Petersburg, , Russia
Saint Petersburg City Oncological Dispensary
Saint Petersburg, , Russia
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
Saint Petersburg, , Russia
Republican oncological dispensary of Republic of Mordovia
Saransk, , Russia
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
Sochi, , Russia
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
Ufa, , Russia
Centro Oncologico Regional de Galicia
A Coruña, , Spain
Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitari Vall DHebron
Barcelona, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
Madrid, , Spain
Dnipropetrovsk City Multifield Clinical Hospital Number 4
Dnipropetrovsk, , Ukraine
National Cancer Institute of the Ministry of Health of Ukraine
Kyiv, , Ukraine
Volyn Regional Oncology Dispensary
Lutsk, , Ukraine
Lviv Regional Oncology Dispensary
Lviv, , Ukraine
Sumy Regional Oncology Center
Sumy, , Ukraine
Zakarpattya Regional Clinical Oncological Dispensary
Uzhhorod, , Ukraine
The Christie NHS Foundation Trust - Clinical Trial Pharmacy
Manchester, England, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Velindre NHS Trust
Cardiff, , United Kingdom
University Hospital of Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Derby Teaching Hospital NHS Foundation Trust
Derby, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
University College London Hospitals
London, , United Kingdom
East and North Hertfordshire NHS Trust
Middlesex, , United Kingdom
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Oza AM, Lisyanskaya A, Fedenko A, de Melo AC, Shparyk Y, Rakhmatullina I, Bondarenko I, Colombo N, Svintsitskiy V, Biela L, Nechaeva M, Lorusso D, Scambia G, Cibula D, Poka R, Oaknin A, Safra T, Mackowiak-Matejczyk B, Ma L, Thomas D, Lin KK, McLachlan K, Goble S, Kristeleit R. Rucaparib versus chemotherapy for treatment of relapsed ovarian cancer with deleterious BRCA1 or BRCA2 mutation (ARIEL4): final results of an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Feb;26(2):249-264. doi: 10.1016/S1470-2045(24)00674-0.
Kristeleit R, Lisyanskaya A, Fedenko A, Dvorkin M, de Melo AC, Shparyk Y, Rakhmatullina I, Bondarenko I, Colombo N, Svintsitskiy V, Biela L, Nechaeva M, Lorusso D, Scambia G, Cibula D, Poka R, Oaknin A, Safra T, Mackowiak-Matejczyk B, Ma L, Thomas D, Lin KK, McLachlan K, Goble S, Oza AM. Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Apr;23(4):465-478. doi: 10.1016/S1470-2045(22)00122-X. Epub 2022 Mar 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000816-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO-338-043
Identifier Type: -
Identifier Source: org_study_id
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