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

This study is currently recruiting participants.
Verified June 2017 by Clovis Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02855944
First Posted: August 4, 2016
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.
July 22, 2016
August 4, 2016
June 16, 2017
September 2016
June 2022   (Final data collection date for primary outcome measure)
Investigator assessed progression-free survival (invPFS) by RECIST Version 1.1 for rucaparib versus chemotherapy [ Time Frame: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for the duration of the study, ~4 years ]
Same as current
Complete list of historical versions of study NCT02855944 on ClinicalTrials.gov Archive Site
  • Efficacy of rucaparib versus chemotherapy as measured by overall survival (OS) [ Time Frame: study data collection expected to last for ~5 years ]
  • Safety and tolerability of rucaparib versus chemotherapy assessed by AEs reported; clinical laboratory investigations; Vital signs; 12 lead ECGs; Physical examinations; and ECOG performance status [ Time Frame: study data collection expected to last for ~4 years ]
    This is a composite outcome. It will be assessed by Incidence, type, seriousness, and severity of AEs reported; clinical laboratory investigations (hematology and serum chemistry); Vital signs (blood pressure, heart rate, and body temperature); 12 lead ECGs; Physical examinations; and ECOG performance status
  • Efficacy of rucaparib versus chemotherapy as measured by overall survival (OS) [ Time Frame: study data collection expected to last for ~5 years ]
  • Safety and tolerability of rucaparib versus chemotherapy [ Time Frame: study data collection expected to last for ~4 years ]
    This is a composite outcome. It will be assessed by Incidence, type, seriousness, and severity of AEs reported; clinical laboratory investigations (hematology and serum chemistry); Vital signs (blood pressure, heart rate, and body temperature); 12 lead ECGs; Physical examinations; and ECOG performance status
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • 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
    • carboplatin/paclitaxel
    • carboplatin/gemcitabine
    • paclitaxel
  • Drug: Rucaparib
    Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice daily
    Other Names:
    • CO-338
    • AG 14699
    • PF 01367338
    • Rubraca
  • Experimental: Rucaparib

    Drug: Oral rucaparib

    600 mg BID Other Names: •CO-338

    • PF 01367338
    • AG 14699
    • Rubraca
    Intervention: Drug: Rucaparib
  • 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.

    Intervention: Drug: Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
345
June 2024
June 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be 18 years of age at the time the informed consent form is signed
  • Have a histologically confirmed 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial Information +1-303-625-5160 (ex-USA) clovistrials@emergingmed.com
Brazil,   Canada,   Czechia,   Hungary,   Israel,   Italy,   Poland,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Czech Republic
 
NCT02855944
CO-338-043
Yes
Not Provided
Not Provided
Clovis Oncology, Inc.
Clovis Oncology, Inc.
Foundation Medicine
Not Provided
Clovis Oncology, Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP