Back to resultsA Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
Primary Purpose
Pancreatic Cancer, Stage IV Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vantictumab
Nab-Paclitaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Stage IV Pancreatic Cancer
Eligibility 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
Sites / Locations
- USC/Norris Comprehensive Cancer Center
- University of Colorado Hospital Anschutz Cancer Pavillion
- Indiana University Simon Cancer Center
- Fox Chase Cancer Center
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Vanctictumab (OMP-18R5)
Nab-Paclitaxel
Gemcitabine
Arm Description
Vantictumab will be administered by intravenous (IV) infusion.
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Gemcitabine will be administered by intravenous (IV) infusion.
Outcomes
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
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
Apparent half life, AUC, clearance, volume of distribution
Full Information
NCT ID
NCT02005315
First Posted
December 3, 2013
Last Updated
September 7, 2020
Sponsor
OncoMed Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02005315
Brief Title
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoMed Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Stage IV Pancreatic Cancer
Keywords
Pancreatic Cancer, Stage IV Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vanctictumab (OMP-18R5)
Arm Type
Experimental
Arm Description
Vantictumab will be administered by intravenous (IV) infusion.
Arm Title
Nab-Paclitaxel
Arm Type
Experimental
Arm Description
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Arm Title
Gemcitabine
Arm Type
Experimental
Arm Description
Gemcitabine will be administered by intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Vantictumab
Other Intervention Name(s)
OMP-18R5
Intervention Description
Administered intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Intervention Description
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered by intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
Description
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel
Time Frame
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Description
Apparent half life, AUC, clearance, volume of distribution
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romnee Clark, MD
Organizational Affiliation
Indiana University Institutional Review Board (IRB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado Hospital Anschutz Cancer Pavillion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
We'll reach out to this number within 24 hrs