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

Completed · Phase 1

Conditions studied: Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT02005315

Run by

OncoMed Pharmaceuticals, Inc.

People needed

30

Starts

2013-09-01

Expected to finish

2017-11-01

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Colorado Hospital Anschutz Cancer Pavillion — Aurora, Colorado, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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