A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

"KAND567 is a drug in capsule and is intended to be orally administered approximately every 12 hours (±1 hour) with an initial loading dose on Day 2 of two times the dose specified for that dose group (e.g., 2 x 250, 2 x 375, 2 x 500, or 2 x 625 mg KAND567, depending on the dose group; in Part 2, this is the RPIID), followed by a KAND567 dose (Day 2, evening dose) that corresponds to the given dose level. On Days 3 to 7, the subjects will be orally administered the specified KAND567 dose (e.g., 250, 375, 500, or 625 mg BID, depending on the dose group; in Part 2, this is the RPIID).~During the second week of dosing (Days 8 to 14) in Part 1 and Part 2, the subjects will be orally administered KAND567 at a dose of 250 mg BID. One treatment cycle is defined as a 21-day period, and each subject will receive up to 6 treatment cycles (or until unacceptable toxicity or disease progression)."

Carboplatin will be administered i.v. according to standard of care at a dose of AUC 5. One cycle is defined as a 21-day period with chemotherapy given on Day 1. Each subject will receive up to 6 treatment cycles (or until unacceptable toxicity or disease progression). The carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target AUC 5 × (GFR + 25). GFR should be calculated using the Cockcroft-Gault formula. The maximum carboplatin dose is based on a calculated GFR that is capped at 125 mL/min for subjects with normal renal function.