ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer; Peritoneal Cancer
• Intervention / Treatment: Drug: Rucaparib; Drug: Chemotherapy

Detailed Description

Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.

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.

• Study Type: Interventional
• Enrollment (Actual): 349
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • Instituto Nacional de Câncer Hospital do Câncer II
  • Sao Paulo, Brazil
    • Hospital Pérola Byington - Centro de Referência da Saúde da Mulher
  • Sao Paulo, Brazil
    • Hospital São Camilo
  • Ceara
    • Fortaleza, Ceara, Brazil
      • Hospital Haroldo Juacaba Instituto do Cancer do Ceara
  • Parana
    • Curitiba, Parana, Brazil
      • Instituto de Oncologia do Parana (IOP)
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil
      • Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS
  • SAO Paulo
    • Barretos, SAO Paulo, Brazil
      • Hospital do Cancer de Barretos
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil
      • CEPON-Centro de Pesquisas Oncológicas
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Tom Baker Cancer Center
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital - General Campus
    • Toronto, Ontario, Canada
      • Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Sherbrooke, Quebec, Canada
      • CIUSSS de l'Estrie CHUS
• Czechia
  • Ostrava, Czechia
    • Fakultni nemocnice Ostrava
  • Praha, Czechia
    • Vseobecna fakultni nemocnice v Praze
  • Jihormoravsky KRAJ
    • Brno, Jihormoravsky KRAJ, Czechia
      • Masarykuv Onkologicky Ustav, Oddeleni komplexni klinicke onkologie
  • Praha
    • Praha 5, Praha, Czechia
      • Fakultni nemocnice v Motole
• Hungary
  • Budapest, Hungary
    • Orszagos Onkologiai Intezet
  • Hajdu-bihar
    • Debrecen, Hajdu-bihar, Hungary
      • Debreceni Egyetem Klinikai Kozpont
• Israel
  • Haifa, Israel
    • Carmel Medical Center
  • Holon, Israel
    • Edith Wolfson Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Organization
  • Petach-Tikva, Israel
    • Rabin Medical Center
  • Ramat Gan, Israel
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center, Oncology Dept.
• Italy
  • Bologna, Italy
    • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • Candiolo, Italy
    • Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo
  • Catania, Italy
    • AO per l'emergenza Cannizzaro
  • Milano, Italy
    • Istituto Europeo di Oncologia
  • Milano, Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Modena, Italy
    • Azienda Ospedaliero-Universitaria Policlinico di Modena
  • Napoli, Italy
    • Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli
• Poland
  • Bialystok, Poland
    • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
  • Lublin, Poland
    • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Olsztyn, Poland
    • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Poznan, Poland
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
  • Szczecin, Poland
    • Pomorska Akademia Medyczna w Szczecinie, Samodzielny Publiczny Szpital Kliniczny Nr 2
  • West Pomeranian Voivodeship
    • Grzybnica, West Pomeranian Voivodeship, Poland
      • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna Sp z o.o.
• Russian Federation
  • Arkhangelsk, Russian Federation
    • Arkhangelsk Clinical Oncological Dispensary
  • Kursk, Russian Federation
    • Kursk Regional Oncologic Dispensary
  • Moscow, Russian Federation, 115478
    • Moscow Clinical Scientific and Practical Center of Moscow Healthcare Department
  • Omsk, Russian Federation
    • Omsk Region Clinical Oncologic Dispensary
  • Pyatigorsk, Russian Federation
    • Pyatigorsk Oncological Dispensary
  • Ryazan, Russian Federation
    • Ryazan Regional Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation
    • Pavlov First Saint-Petersburg State Medical University
  • Saint Petersburg, Russian Federation
    • State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
  • Saint-Petersburg, Russian Federation
    • Saint Petersburg City Oncological Dispensary
  • Saransk, Russian Federation
    • Republican oncological dispensary of Republic of Mordovia
  • Sochi, Russian Federation
    • State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
  • Ufa, Russian Federation
    • Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
• Spain
  • Barcelona, Spain
    • Hospital Duran I Reynals
  • Barcelona, Spain
    • Hospital Universitari Vall dHebron
  • Girona, Spain
    • Hospital Universitari de Girona Doctor Josep Trueta
  • La Coruna, Spain
    • Centro Oncologico Regional de Galicia
  • Madrid, Spain
    • Hospital Clínico 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
• Ukraine
  • Dnipropetrovsk, Ukraine
    • Dnipropetrovsk City Multifield Clinical Hospital Number 4
  • Kyiv, Ukraine
    • National Cancer Institute of the Ministry of Health of Ukraine
  • Lutsk, Ukraine
    • Volyn Regional Oncology Dispensary
  • Lviv, Ukraine
    • Lviv Regional Oncology Dispensary
  • Sumy, Ukraine
    • Sumy Regional Oncology Center
  • Uzhgorod, Ukraine
    • Zakarpattya Regional Clinical Oncological Dispensary
• United Kingdom
  • Cambridge, United Kingdom
    • Cambridge University Hospitals NHS Foundation Trust
  • Cardiff, United Kingdom
    • Velindre NHS Trust
  • Coventry, United Kingdom
    • University Hospital of Coventry and Warwickshire NHS Trust
  • Derby, United Kingdom
    • Derby Teaching Hospital NHS Foundation Trust
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom
    • University College London Hospitals
  • Middlesex, United Kingdom
    • East and North Hertfordshire NHS Trust
  • Newcastle upon Tyne, United Kingdom
    • Newcastle Hospitals NHS Foundation Trust
  • England
    • Manchester, England, United Kingdom
      • The Christie NHS Foundation Trust - Clinical Trial Pharmacy
  • Surrey
    • Sutton, Surrey, United Kingdom
      • The Royal Marsden NHS Foundation Trust
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be 18 years of age at the time the informed consent form is signed
• 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:

• History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rucaparib; Drug: Oral rucaparib 600 mg BID (twice a day) Other Names: CO-338; PF 01367338; AG 14699; Rubraca	Drug: Rucaparib; Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day; Other Names: Rubraca; CO-338; PF 01367338; AG 14699
Active Comparator: 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.	Drug: Chemotherapy; Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.; Other Names: Cisplatin; carboplatin; paclitaxel; carboplatin/paclitaxel; carboplatin/gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)	The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)	The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)	A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)	A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)	A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)	A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population)	A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or response per Gynecologic Cancer InterGroup Cancer Antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population)	A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or response per Gynecologic Cancer InterGroup Cancer Antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response.	Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)	EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.	Baseline to the end of Cycle 6, or up to approximately 6 months
Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)	EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.	Baseline to the end of Cycle 6, or up to approximately 6 months
Overall Survival (Efficacy Population)	Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.	All patients were followed for survival up to approximately 3.5 years.
Overall Survival (ITT Population)	Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.	All patients were followed for survival up to approximately 3.5 years.

Collaborators and Investigators

• Sponsor: zr Pharma & GmbH
• Collaborators: Foundation Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): December 3, 2020
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimated): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PARP Inhibitor; ovarian cancer; fallopian tube cancer; primary peritoneal cancer; homologous recombination deficiency; PARP; peritoneal cancer; gynecological cancer; platinum sensitive; CO-338; Clovis; Rubraca; platinum resistant ovarian cancer; Partially platinum sensitive; rucaparib; PF 01367338; ARIEL3; ARIEL 3; homologous recombination; platinum sensitive ovarian cancer; platinum sensitive fallopian tube cancer; platinum sensitive primary peritoneal cancer; platinum sensitive peritoneal cancer; High grade serous; relapsed disease; ruca; genomic scarring; loss of heterozygosity; PF-01367338; CO-338-043; Clovis oncology; ARIEL2; ARIEL 2; ARIEL-2; ARIEL-3; ARIEL4; ARIEL-4; ARIEL 4; A4; advanced OC; platinum resistant primary ovarian cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Poly(ADP-ribose) Polymerase Inhibitors; Carboplatin; Paclitaxel; Cisplatin; Albumin-Bound Paclitaxel; Rucaparib; Gemcitabine
• Other Study ID Numbers: CO-338-043; 2016-000816-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No