NCT02005315

A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer

A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.

Detailed description

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 vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.

Conditions

• Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Vantictumab	Administered intravenous (IV) infusion.
DRUG	Nab-Paclitaxel	Nab-Paclitaxel will be administered by intravenous (IV) infusion.
DRUG	Gemcitabine	Gemcitabine will be administered by intravenous (IV) infusion.

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-10-01
• Completion: 2017-11-01
• First posted: 2013-12-09
• Last updated: 2020-09-09

Locations

5 sites across 1 country: United States