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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01292655
Collaborator
(none)
94
Enrollment
8
Locations
4
Arms
75.7
Actual Duration (Months)
11.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors
Actual Study Start Date :
Mar 3, 2011
Actual Primary Completion Date :
Jun 22, 2017
Actual Study Completion Date :
Jun 22, 2017

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with adverse events as a measure of safety and tolerability [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

    1. Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1 [Tumor assessments at least every 8 weeks during treatment period]

    2. PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies [PD changes from baseline during the first 4-5 weeks of dosing]

    3. PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax) [PK at multiple time points during the first 8 weeks of dosing]

    4. PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin) [PK at multiple time points during the first 8 weeks of dosing]

    5. PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax) [PK at multiple time points during the first 8 weeks of dosing]

    6. PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half) [PK at multiple time points during the first 8 weeks of dosing]

    7. PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI) [PK at multiple time points during the first 8 weeks of dosing]

    8. PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC) [PK at multiple time points during the first 8 weeks of dosing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anthony El-Khoueiry, Md Los Angeles California United States 90033
    2 Winship Cancer Institute. Atlanta Georgia United States 30322
    3 Wayne State University Detroit Michigan United States 48201
    4 University Of Mississippi Medical Center Jackson Mississippi United States 39216
    5 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    6 The Methodist Hospital Research Institute Houston Texas United States 77030
    7 Local Institution Parkville Victoria Australia 3050
    8 Local Institution Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01292655
    Other Study ID Numbers:
    • CA216-001
    First Posted:
    Feb 9, 2011
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 27, 2020