Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

January 24, 2020 updated by: Bristol-Myers Squibb

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Local Institution
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Anthony El-Khoueiry, Md
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Subjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalation
  • Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
  • Biopsy accessible tumor (may be waived under certain circumstances)
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Infection
  • Elevated triglycerides
  • Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
  • Taking medications known to increase risk of Torsades De Pointes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A1 (Escalation): BMS-906024
BMS-906024 solution intravenously as specified
Drug: BMS-906024
Other Names:
  • BMS-906024 (Notch inhibitor)
Experimental: Arm A2 (Expansion): BMS-906024
BMS-906024 solution intravenously as specified
Drug: BMS-906024
Other Names:
  • BMS-906024 (Notch inhibitor)
Experimental: Arm B1 (Escalation): BMS-906024
BMS-906024 solution intravenously as specified
Drug: BMS-906024
Other Names:
  • BMS-906024 (Notch inhibitor)
Experimental: Arm B2 (Expansion): BMS-906024
BMS-906024 solution intravenously as specified
Drug: BMS-906024
Other Names:
  • BMS-906024 (Notch inhibitor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year
Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1
Time Frame: Tumor assessments at least every 8 weeks during treatment period
Tumor assessments at least every 8 weeks during treatment period
PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies
Time Frame: PD changes from baseline during the first 4-5 weeks of dosing
PD changes from baseline during the first 4-5 weeks of dosing
PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)
Time Frame: PK at multiple time points during the first 8 weeks of dosing
PK at multiple time points during the first 8 weeks of dosing
PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)
Time Frame: PK at multiple time points during the first 8 weeks of dosing
PK at multiple time points during the first 8 weeks of dosing
PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)
Time Frame: PK at multiple time points during the first 8 weeks of dosing
PK at multiple time points during the first 8 weeks of dosing
PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)
Time Frame: PK at multiple time points during the first 8 weeks of dosing
PK at multiple time points during the first 8 weeks of dosing
PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)
Time Frame: PK at multiple time points during the first 8 weeks of dosing
PK at multiple time points during the first 8 weeks of dosing
PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC)
Time Frame: PK at multiple time points during the first 8 weeks of dosing
PK at multiple time points during the first 8 weeks of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2011

Primary Completion (Actual)

June 22, 2017

Study Completion (Actual)

June 22, 2017

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CA216-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on BMS-906024

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe