Brief Title
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
Official Title
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3)
Brief Summary
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 evaluate patient response
to maintenance treatment with rucaparib versus placebo. Response to treatment will be
analyzed based on homologous recombination (HR) status of tumor samples.
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 tumor HRD status.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
Secondary Outcome
Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)
Condition
Ovarian Cancer
Intervention
Rucaparib
Study Arms / Comparison Groups
Rucaparib
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
564
Start Date
April 7, 2014
Completion Date
June 2020
Primary Completion Date
April 2017
Eligibility 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 including platinum based regimen
that must have been administered immediately prior to maintenance therapy in this
trial.
- Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will
not be counted as a non-platinum regimen.
- Must have had at least a 6-month disease-free period following prior treatment with
the penultimate platinum-based chemotherapy and achieved a response.
- For the last chemotherapy course prior to study entry, patients must have received a
platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined
by RECIST) and/or a GCIG CA-125 response.
- Have sufficient archival tumor tissue for analysis.
Exclusion Criteria:
- History of prior cancer except for non-melanoma skin cancer, breast cancer curatively
> 3 years ago, 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.
- Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
in the opinion of the Investigator, interfere with absorption of study drug.
- Required drainage of ascites during the final 2 cycles of their last platinum-based
regimen and/or during the period between the last dose of chemotherapy of that regimen
and randomization to maintenance treatment in this study.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Heidi Giordano, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01968213
Organization ID
CO-338-014
Responsible Party
Sponsor
Study Sponsor
Clovis Oncology, Inc.
Collaborators
Foundation Medicine
Study Sponsor
Heidi Giordano, Study Director, Clovis Oncology, Inc.
Verification Date
February 2020