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

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ClinicalTrials.gov Identifier: NCT02855944
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE July 22, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date July 2, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02855944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
345
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Brazil,   Canada,   Czechia,   Hungary,   Israel,   Italy,   Poland,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02855944
Other Study ID Numbers  ICMJE CO-338-043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clovis Oncology, Inc.
Study Sponsor  ICMJE Clovis Oncology, Inc.
Collaborators  ICMJE Foundation Medicine
Investigators  ICMJE Not Provided
PRS Account Clovis Oncology, Inc.
Verification Date April 2019

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