Spots Global Cancer Trial Database for Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
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Trial Identification
Brief Title: Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
Official Title: Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy
Study ID: NCT02983799
Interventions
Study Description
Brief Summary: This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Subjects should have received at least 1 prior line of platinum-based chemotherapy.
Detailed Description: This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily (bid) in subjects with platinum-sensitive or partially platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received at least 1 prior line of platinum-based chemotherapy. The study will assess the effectiveness of olaparib tablets as measured by the objective response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in subjects with germline BRCA mutations (gBRCAm), somatic BRCA mutations (sBRCAm), or potential aberrations in homologous recombination deficiency (HRD) as determined by myChoice® HRD, as well as in subjects without identifiable HRD. This study will utilize Myriad BRACAnalysis CDx® for germline BRCA analysis and a tumor test (myChoice® HRD) for tumor BRCA analysis and HRD status. Four cohorts will be identified based upon the genetic testing described above: * Cohort 1: gBRCAm, * Cohort 2: sBRCAm and germline BRCA wild type, * Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type (BRCAwt) (no BRCA mutation), * Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA mutation).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Anchorage, Alaska, United States
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Aurora, Colorado, United States
Research Site, Hartford, Connecticut, United States
Research Site, New Haven, Connecticut, United States
Research Site, Newark, Delaware, United States
Research Site, South Miami, Florida, United States
Research Site, Skokie, Illinois, United States
Research Site, Shreveport, Louisiana, United States
Research Site, Silver Spring, Maryland, United States
Research Site, Springfield, Massachusetts, United States
Research Site, Detroit, Michigan, United States
Research Site, Detroit, Michigan, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Saint Paul, Minnesota, United States
Research Site, Berkeley Heights, New Jersey, United States
Research Site, Hackensack, New Jersey, United States
Research Site, Newark, New Jersey, United States
Research Site, Teaneck, New Jersey, United States
Research Site, Bronx, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Abington, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Providence, Rhode Island, United States
Research Site, Germantown, Tennessee, United States
Research Site, Houston, Texas, United States
Research Site, Annandale, Virginia, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Edmonton, Alberta, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, Winnipeg, Manitoba, Canada
Research Site, Halifax, Nova Scotia, Canada
Research Site, Hamilton, Ontario, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Mississauga, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Sherbrooke, Quebec, Canada
Contact Details
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