A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Therapy Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Prim
The purposes of this study are: to look at the effects, good and/or bad, the study drug has on patients and their disease; to look for biomarkers in samples of tumor tissue and blood to find out if patients with this type of cancer respond or do not respond to rucaparib; to learn about how patients feel while they are taking the study drug; and to measure the amount of rucaparib in patient's blood at different times.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
1. Be 18 years of age or older.
2. Have a histologically confirmed diagnosis of high-grade (Grade 2 or 3) serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer.
3. Have received prior platinum-based therapy and have platinum-sensitive disease.
4. Achieved best response of either CR or PR to the most recent platinum-based regimen administered and is randomized to study treatment within 8 weeks of the last dose of platinum received.
5. Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses.
6. Have CA-125 measurement that is < ULN.
7. Have ECOG performance status of 0 to 1.
8. Have adequate organ function confirmed by laboratory values obtained within 14 days of the first dose of study drug.
9. Patients who previously received treatment with any PARP inhibitor are not eligible.
10. Patients who 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 are not eligible.
11. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks. Patients with symptomatic and/or untreated central nervous system (CNS) metastases are not eligible.
12. No 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.
13. Patients with known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C are not eligible.
14. Patients who are pregnant or breast feeding are not eligible.
15. Patients who received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs are not eligible.
16. Patients who have on-going requirements for strong CYP1A2 or CYP3A4 inhibitors are not eligible.
17. Patient must be sufficiently recovered and stable from any non-study related minor surgical procedure.
Primary disease category: Cancer
Secondary disease categories: Women's Health
Sponsor: Clovis Oncology, Inc
Protocol number: CO-338-014
Projected enrollment dates: March 2015 to January 2017
Official study title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Therapy Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer