Back to resultsA Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
brontictuzumab
trifluridine/tipiracil
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
- ECOG performance status 0 or 1
Exclusion Criteria:
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
- Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug
Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:
- Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
- Active peptic ulcer disease
- Known intraluminal metastatic lesion(s) with risk of bleeding
Sites / Locations
- Denver
- Miami
- Sarasota
- Charleston
- Nashville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brontictuzumab and trifluridine/tipiracil
Arm Description
Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
Outcomes
Primary Outcome Measures
Percentage of patients with adverse events
Percentage of patients with dose limiting toxicities
Percentage of patients with anti-brontictuzumab antibodies
Secondary Outcome Measures
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Changes in number of circulating tumor cells
Overall survival
Full Information
NCT ID
NCT03031691
First Posted
January 13, 2017
Last Updated
August 10, 2020
Sponsor
OncoMed Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03031691
Brief Title
A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Official Title
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
September 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
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.
Detailed Description
This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for up to 24 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 34 patients will be enrolled in this study at approximately 5 study centers in the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brontictuzumab and trifluridine/tipiracil
Arm Type
Experimental
Arm Description
Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
Intervention Type
Drug
Intervention Name(s)
brontictuzumab
Other Intervention Name(s)
OMP-52M51
Intervention Description
starting dose of 1.5mg/kg administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
trifluridine/tipiracil
Primary Outcome Measure Information:
Title
Percentage of patients with adverse events
Time Frame
up to approximately 2 years
Title
Percentage of patients with dose limiting toxicities
Time Frame
28 days
Title
Percentage of patients with anti-brontictuzumab antibodies
Time Frame
up to approximately 2 years
Secondary Outcome Measure Information:
Title
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time Frame
approximately 2 years
Title
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Time Frame
approximately 2 years
Title
Changes in number of circulating tumor cells
Time Frame
approximately 2 years
Title
Overall survival
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
ECOG performance status 0 or 1
Exclusion Criteria:
Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug
Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:
Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
Active peptic ulcer disease
Known intraluminal metastatic lesion(s) with risk of bleeding
Facility Information:
Facility Name
Denver
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Sarasota
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Charleston
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Nashville
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
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