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

September 7, 2020 updated by: OncoMed Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital Anschutz Cancer Pavillion
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vanctictumab (OMP-18R5)
Vantictumab will be administered by intravenous (IV) infusion.
Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Names:
  • OMP-18R5
Drug: Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Drug: Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
Experimental: Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Names:
  • OMP-18R5
Drug: Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Drug: Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
Experimental: Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Names:
  • OMP-18R5
Drug: Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Drug: Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
Time Frame: 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
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OncoMed Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Romnee Clark, MD, Indiana University Institutional Review Board (IRB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18R5-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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