Trial record 1 of 32 for:    18R5-003
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A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02005315
First received: December 3, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Pancreatic Cancer
Stage IV Pancreatic Cancer
Drug: Vantictumab
Drug: Nab-Paclitaxel
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Apparent half life, AUC, clearance, volume of distribution


Estimated Enrollment: 34
Study Start Date: September 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005315

Locations
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Heinz-Josef Lenz, MD    (323) 865-3955    lenz@usc.edu   
Principal Investigator: Heinz-Josef Lenz, M.D., F.A.C.P.         
United States, Colorado
Anschutz Cancer Pavillion Recruiting
Aurora, Colorado, United States, 80045
Contact: Wells A Messersmith, MD, FACP    720-848-0300    wells.messersmith@ucdenver.edu   
Principal Investigator: Wells A Messersmith, MD, FACP         
United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Romnee Clark, MD    317-948-7576    rc2@iupui.edu   
Principal Investigator: Romnee Clark, MD         
lU Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Safi Shahda, MD    317-948-6942    shahdas@iu.edu   
Principal Investigator: Safi Shahda, M.D.         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Steven Cohen, M.D.    215-728-3450    steven.cohen@fccc.edu   
Principal Investigator: Steven Cohen, MD         
United States, Tennessee
Henry-Joyce Cancer Clinic Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jordan Berlin, MD    615-343-4967    jordan.berlin@vanderbilt.edu   
Principal Investigator: Jordan Belin, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Investigators
Principal Investigator: Romnee Clark, MD Indiana University Institutional Review Board (IRB)
  More Information

No publications provided

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02005315     History of Changes
Other Study ID Numbers: 18R5-003
Study First Received: December 3, 2013
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Pancreatic Cancer
Stage IV Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014