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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: BMS-906024

• Registration Number: NCT01292655
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Study Start: 2011-03-03
• Primary Completion: 2017-06-22
• Study Completion: 2017-06-22
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A1 (Escalation): BMS-906024	BMS-906024	BMS-906024 solution intravenously as specified
Arm A2 (Expansion): BMS-906024	BMS-906024	BMS-906024 solution intravenously as specified
Arm B1 (Escalation): BMS-906024	BMS-906024	BMS-906024 solution intravenously as specified
Arm B2 (Expansion): BMS-906024	BMS-906024	BMS-906024 solution intravenously as specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1	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	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)	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)	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)	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)	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)	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)	PK at multiple time points during the first 8 weeks of dosing

Trial Locations

Locations (7)

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Local Institution; 🇨🇦 Toronto, Ontario, Canada

Winship Cancer Institute.; 🇺🇸 Atlanta, Georgia, United States

University Of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Anthony El-Khoueiry, Md; 🇺🇸 Los Angeles, California, United States

The Methodist Hospital Research Institute; 🇺🇸 Houston, Texas, United States