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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.

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date January 24, 2018
Actual Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02005315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Cancer
  • Stage IV Pancreatic Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Vanctictumab (OMP-18R5)
    Vantictumab will be administered by intravenous (IV) infusion.
    Interventions:
    • Drug: Vantictumab
    • Drug: Nab-Paclitaxel
    • Drug: Gemcitabine
  • Experimental: Nab-Paclitaxel
    Nab-Paclitaxel will be administered by intravenous (IV) infusion.
    Interventions:
    • Drug: Vantictumab
    • Drug: Nab-Paclitaxel
    • Drug: Gemcitabine
  • Experimental: Gemcitabine
    Gemcitabine will be administered by intravenous (IV) infusion.
    Interventions:
    • Drug: Vantictumab
    • Drug: Nab-Paclitaxel
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
34
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005315
Other Study ID Numbers  ICMJE 18R5-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OncoMed Pharmaceuticals, Inc.
Study Sponsor  ICMJE OncoMed Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Romnee Clark, MD Indiana University Institutional Review Board (IRB)
PRS Account OncoMed Pharmaceuticals, Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP