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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncoMed Pharmaceuticals, Inc.
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Signed Informed Consent Form

• Age ≥18 years

• Histologically documented Stage IV ductal adenocarcinoma of the pancreas

• Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy

• ECOG performance status of 0 or 1

• Adequate hematologic and end-organ function

• Evaluable or measurable disease per RECIST v1.1

• For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

• Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer

• Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas

• Known hypersensitivity to any component of study treatments

• Known brain metastases, uncontrolled seizure disorder, or active neurologic disease