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

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ClinicalTrials.gov Identifier: NCT02005315
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Stage IV Pancreatic Cancer Drug: Vantictumab Drug: Nab-Paclitaxel Drug: Gemcitabine Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Vanctictumab (OMP-18R5)
Vantictumab will be administered by intravenous (IV) infusion.
 Drug: Vantictumab
Administered intravenous (IV) infusion.
Other Name: 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 Name: 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 Name: OMP-18R5

Drug: Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.

Drug: Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005315


Locations
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United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Hospital Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Romnee Clark, MD Indiana University Institutional Review Board (IRB)
More Information
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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02005315     History of Changes
Other Study ID Numbers: 18R5-003
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Keywords provided by OncoMed Pharmaceuticals, Inc.:
Pancreatic Cancer
Stage IV Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs