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A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031691
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date August 11, 2020
Study Start Date  ICMJE January 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Percentage of patients with adverse events [ Time Frame: up to approximately 2 years ]
  • Percentage of patients with dose limiting toxicities [ Time Frame: 28 days ]
  • Percentage of patients with anti-brontictuzumab antibodies [ Time Frame: up to approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: approximately 2 years ]
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [ Time Frame: approximately 2 years ]
  • Changes in number of circulating tumor cells [ Time Frame: approximately 2 years ]
  • Overall survival [ Time Frame: approximately 2 years ]
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 Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: brontictuzumab
    starting dose of 1.5mg/kg administered intravenously (IV)
    Other Name: OMP-52M51
  • Drug: trifluridine/tipiracil
Study Arms  ICMJE Experimental: Brontictuzumab and trifluridine/tipiracil
Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
Interventions:
  • Drug: brontictuzumab
  • Drug: trifluridine/tipiracil
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: May 31, 2017)		 7
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)		 34
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT03031691
Other Study ID Numbers  ICMJE 52M51-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE OncoMed Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mereo BioPharma
Verification Date August 2020

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