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Trial record 2 of 36 for:    clovis oncology

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)

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ClinicalTrials.gov Identifier: NCT01968213
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Last Update Posted : May 19, 2017
Sponsor:
Collaborators:
Foundation Medicine
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Rucaparib Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : January 2014
Actual Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rucaparib
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Disease progression according to RECIST Version 1.1, as assessed by the investigator, or death from any cause (investigator Progression Free Survival or invPFS), in molecularly defined subgroups [ Time Frame: Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years. ]

Secondary Outcome Measures :
  1. 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: Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years. ]
  2. 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. ]
  3. 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. ]
  4. Overall Survival (OS) [ Time Frame: Continuously for ~5 years after patient enrolls into study. ]
  5. Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications [ Time Frame: Continuously for ~3 years after patient enrolls into study. ]
  6. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 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 duodental 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968213


  Show 85 Study Locations
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine
Myriad Genetics, Inc.
Investigators
Study Director: Heidi Giordano Clovis Oncology, Inc.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01968213     History of Changes
Other Study ID Numbers: CO-338-014
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Digestive System Diseases
Peritoneal Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents