Ovarian Cancer Clinical Trial
Official title:
A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL • min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and carboplatin will be given. Additional cycles may be given as per institutional standard of care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg.
Depending on safety in this study, additional lower or intermediate dose levels may be
evaluated. Depending on emerging safety data from the Phase 1a study 54F28-001 with
continuing dose escalation, additional higher dose levels of OMP-54F28 may be evaluated in
this study. Alternative dosing schedules of OMP-54F28 may be explored based on emerging
nonclinical and clinical data for safety, PD, PK and efficacy. The starting dose for a new
dosing schedule will be chosen to result in an AUC equivalent to the highest dose level that
cleared on the previously studied dosing schedule. No dose escalation of OMP-54F28 will be
allowed within a dose cohort.
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
safety, tolerability and PK of OMP-54F28 combined with paclitaxel and carboplatin. Up to
approximately 34 patients may be enrolled into the study.
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