NCT01647828

A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.

Conditions

• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	OMP-59R5	OMP-59R5 administered intravenously
DRUG	Gemcitabine	administered intravenously
DRUG	Placebo	administered IV
DRUG	Nab-Paclitaxel	administered intravenously

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-07-24
• Last updated: 2023-02-15
• Results posted: 2023-02-15

Locations

26 sites across 1 country: United States