Cancer
Conditions
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.
Interventions
DRUGBMS-906024
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1 | Tumor assessments at least every 8 weeks during treatment period |
| 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 |
| 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 |
Countries
Australia, Canada, United States
Outcome results
None listed