drugset / Trial / NCT02050178
Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-11
- Primary completion
- 2017-06-15
- Completion
- 2017-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IPAFRICEPT | Protein / enzyme biologic | 3.5 mg/kg | Intravenous |
| Subject | IPAFRICEPT | Protein / enzyme biologic | 7 mg/kg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |