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Title:
(CO-338-014) A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 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
Protocol Number:
J13168
Phase:
Phase III
Physician:
Deborah Armstrong
Purpose:
ARIEL3 is a Phase 3 clinical trial to determine whether an investigational drug, rucaparib, is safe and effective. The purpose of the ARIEL3 study is to compare the effects of rucaparib vs a placebo (sugar pill) in approximately 540 women with platinum-sensitive high-grade ovarian, fallopian tube, or primary peritoneal cancer
Eligibility:
You may be eligible to enroll in ARIEL3 if- You have high-grade ovarian (serous or endometrioid subtype), fallopian tube, or primary peritoneal cancer- You have tumor tissue from a prior surgery or biopsy procedure available for testing- You have received equal to 2 prior platinum-based treatment regimens (for example, carboplatin or cisplatin)- You have a tumor that previously responded well to treatment with a platinum (ie, your disease did not progress for at least 6 months after the last dose of platinum)- You are also receiving or have just completed treatment with a platinum regimen and have had a good response to this recent treatment- You have not received prior treatment with a PARP inhibitor (for example, olaparib, veliparib, niraparib, BMN 673, or rucaparib)
Treatment:
If you qualify for the ARIEL3 trial, you will receive the following as part of the study:– Study-related physical exams– Lab tests, including BRCA and other molecular marker tests– The study medication (rucaparib) or placeboTwo-thirds of the participants enrolled in this study will receive rucaparib and one-third will receive placeboWhat is rucaparib?- Rucaparib is an investigational oral (taken by mouth) drug being tested in women with ovarian cancer- It is designed to inhibit poly (ADP-ribose) polymerase (PARP), a protein involved in one of the ways that DNA is repaired- Rucaparib has not been approved in any country for use as a prescription medicine. It is currently available only in clinical trials
Population:
Adult
Last Update
11/26/2014 04:10 AM
 

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