Overview

This trial is active, not recruiting.

Condition cancer
Treatment bms-906024
Phase phase 1
Sponsor Bristol-Myers Squibb
Start date March 2011
End date October 2016
Trial size 110 participants
Trial identifier NCT01292655, CA216-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BMS-906024 solution intravenously as specified
bms-906024 BMS-906024 (Notch inhibitor)
(Experimental)
BMS-906024 solution intravenously as specified
bms-906024 BMS-906024 (Notch inhibitor)
(Experimental)
BMS-906024 solution intravenously as specified
bms-906024 BMS-906024 (Notch inhibitor)
(Experimental)
BMS-906024 solution intravenously as specified
bms-906024 BMS-906024 (Notch inhibitor)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1
time frame: 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
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 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 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 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 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 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.
Location data was received from the National Cancer Institute and was last updated in May 2016.