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

Phase 1

Completed

• Conditions: Pancreatic Cancer; Stage IV Pancreatic Cancer
• Interventions: Drug: Vantictumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine

• Registration Number: NCT02005315
• Lead Sponsor: OncoMed Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2017-10
• Study Completion: 2017-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine	Nab-Paclitaxel	Gemcitabine will be administered by intravenous (IV) infusion.
Vanctictumab (OMP-18R5)	Nab-Paclitaxel	Vantictumab will be administered by intravenous (IV) infusion.
Nab-Paclitaxel	Nab-Paclitaxel	Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Vanctictumab (OMP-18R5)	Gemcitabine	Vantictumab will be administered by intravenous (IV) infusion.
Nab-Paclitaxel	Vantictumab	Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Nab-Paclitaxel	Gemcitabine	Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Gemcitabine	Vantictumab	Gemcitabine will be administered by intravenous (IV) infusion.
Gemcitabine	Gemcitabine	Gemcitabine will be administered by intravenous (IV) infusion.
Vanctictumab (OMP-18R5)	Vantictumab	Vantictumab will be administered by intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer	Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)	The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer	Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.	Apparent half life, AUC, clearance, volume of distribution

Trial Locations

Locations (5)

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Colorado Hospital Anschutz Cancer Pavillion; 🇺🇸 Aurora, Colorado, United States