A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (ARIEL3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Clovis Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01968213
First received: October 17, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: Rucaparib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3)

Resource links provided by NLM:


Further study details as provided by Clovis Oncology, Inc.:

Primary Outcome Measures:
  • Disease progression according to RECIST Version 1.1 (v1.1), as assessed by the investigator, or death from any cause (investigator Progression Free Survival or invPFS), in molecularly defined subgroups [ Time Frame: Screening, within 7 days prior to the end of every 3rd cycle of treament, and Treatment Discontinuation visit. Study data collection expected to last for ~3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease progression according to RECIST v1.1, as assessed by Independent Radiology Review (IRR), or death from any cause (irrPFS), in molecularly defined subgroups [ Time Frame: Screening, within 7 days prior to the end of every 3rd cycle of treament, and Treatment Discontinuation visit. Study data collection expected to last for ~3 years. ] [ Designated as safety issue: No ]
  • Time to a specified decrease in the DSR P subscale of the FOSI-18 patient reported outcome questionnaire [ Time Frame: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years. ] [ Designated as safety issue: No ]
  • Time to a specified decrease in the total score of the FOSI-18 patient reported outcome questionnaire [ Time Frame: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years. ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Continuously for ~5 years after patient enrolls into study. ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications [ Time Frame: Continuously for ~3 years after patient enrolls into study. ] [ Designated as safety issue: Yes ]
  • Individual model parameter estimates of rucaparib and covariates identification (PK) [ Time Frame: Cycle 1 Day 15, and Cycle 2 Day 1, Cycle 2 Day 15, Cycle 4 Day 1, and Cycle 7 Day 1. Study data collection expected to last for ~7 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: January 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rucaparib
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Drug: Rucaparib
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Other Name: CO-338; PF 01367338, AG 14699
Placebo Comparator: Placebo
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Drug: Placebo
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

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). Clinical data have shown that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment with a PARP and that maintenance treatment with a PARP inhibitor following a response to platinum-based treatment increases PFS in patients with ovarian cancer. While patients with a BRCA mutation derived the most benefit, patients without evidence of a BRCA mutation also derived significant benefit.

Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib. It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Received ≥2 prior platinum-based treatment regimens.
  • Received no more than 1 non-platinum regimen.
  • Must have had at least a 6-month disease-free period following prior treatment with platinum-based chemotherapy and achieved a response.
  • Have sufficient archival tumor tissue for analysis.

Exclusion Criteria:

  • History of prior cancer except for non-melanoma skin cancer, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer.
  • Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible.
  • Untreated or symptomatic central nervous system metastases.
  • Prior gastrectomy or upper bowel removal or any gastrointestinal disorder that would interfere with the absorption of rucaparib.
  • Required drainage of ascites fluid during end of chemotherapy treatment or after completion of chemotherapy treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968213

Contacts
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

  Show 98 Study Locations
Sponsors and Collaborators
Clovis Oncology, Inc.
Investigators
Study Director: Heidi Giordano Clovis Oncology, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01968213     History of Changes
Other Study ID Numbers: CO-338-014
Study First Received: October 17, 2013
Last Updated: October 6, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
France: Ministry of Health
Germany: Ministry of Health
Israel: Ministry of Health
Italy: Ministry of Health
New Zealand: Ministry of Health
Spain: Ministry of Health
United Kingdom: National Health Service
United States: Food and Drug Administration

Keywords provided by Clovis Oncology, Inc.:
ARIEL3
ARIEL 3
platinum sensitive
PARP Inhibitor
rucaparib
homologous recombination
homologous recombination deficiency
CO-338
PF 01367338
AG 14699
platinum sensitive ovarian cancer
platinum sensitive fallopian tube cancer
platinum sensitive primary peritoneal cancer
platinum sensitive peritoneal cancer
gynecological cancer
Clovis
Clovis Oncology

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014