Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

Completed · Phase 3 · Has a placebo group

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT01968213

Run by

pharmaand GmbH

People needed

564

Starts

2014-04-07

Expected to finish

2022-07-07

Last updated by the study team

2023-06-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Saint Jude Heritage Medical Center — Fullerton, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of California San Francisco (UCSF) — San Francisco, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Central Coast Medical Oncology — Santa Maria, California, United States
• University of California Los Angeles (UCLA) — Santa Monica, California, United States
• Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Johns Hopkins Universty — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute - Wayne State University — Detroit, Michigan, United States
• Washington University School of Medicine - Division of Gynaecological Oncology — St Louis, Missouri, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Hope Women's Cancer Centers — Asheville, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington at Seattle — Seattle, Washington, United States
• Prince of Wales Hospital — Sydney, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Royal Brisbane & Women's Hospital — Herston, Queensland, Australia
• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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