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A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Rucaparib in Patients With Advanced Breast, Ovarian, or Prostate Cancer
This is a dose escalation and expansion trial. Before Cycle 1, Part 1, eligible (advanced breast cancer, ovarian cancer, or prostate cancer) patients will receive a 7-day run-in period with ipatasertib alone. This will be followed by ipatasertib and rucaparib combination treatment on Cycle 1, Day 1 in the 28 Day Cycle. Patients enrolled in part 1 of the trial will be split into 4 cohorts, each receiving differing dose levels of the study drug: Dose Level 1 group - 300 mg ipatasertib once daily (QD) + 400 mg rucaparib twice daily (BID), Dose Level 2a: 300 mg ipatasertib QD + 600 mg rucaparib BID, Dose Level 2b: 400 mg ipatasertib QD + 400 mg rucaparib BID, Dose Level 3: 400 mg ipatasertib QD + 600 mg rucaparib BID.
Only patients with advanced prostate cancer will be enrolled in part two of the trial, which is the dose expansion phase. These patients will receive a recommended dose, as advised in part one.