Pancreatic Cancer Clinical Trial
Official title:
A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) will be administered IV on Days 1, 8, and 15 of each cycle. The planned dose levels of OMP-54F28 are 3.5 mg/kg and 7.0 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. 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 nab-paclitaxel and gemcitabine. Up to
approximately 34 patients may be enrolled into the study.
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