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(Non-safety reason, business objectives have changed)
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The primary purpose of this study is to evaluate the safety and effectiveness of daily doses of BMS-986115 in subjects with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Dose Escalation (BMS-986115) | Experimental | Continuous daily dosing until disease progression or unacceptable toxicity |
|
| Arm A: Dose Expansion (BMS-986115) | Experimental | Continuous daily dosing until disease progression or unacceptable toxicity |
|
| Arm B: Dose Escalation (BMS-986115) | Experimental | Twice weekly dosing until disease progression or unacceptable toxicity |
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| Arm B: Dose Expansion (BMS-986115) | Experimental | Twice weekly dosing until disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986115 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple daily doses of BMS-986115 | Measured by the frequency of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, Grade 3 or 4 AEs, deaths, laboratory abnormalities and clinically relevant electrocardiogram (ECG) changes from baseline | Up to 30 days after the last dose of study medication (approximately 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986115 and its active metabolite BMT-100948 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usc/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| Local Institution |
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| ID | Term |
|---|---|
| C000631573 | BMS-986115 |
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| 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Trough observed plasma concentration (Ctrough) of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Terminal plasma half-life (T-HALF) of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Apparent total body clearance (CLT/F) of BMS-986115 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Apparent volume of distribution at steady-state (Vz/F) of BMS-986115 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986115 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Ratio of metabolite AUC(INF) to parent AUC(INF) after single dose and ratio of metabolite AUC(TAU) to parent AUC(TAU) at steady state, corrected for molecular weight (MR_AUC) of BMS-986115 and its active metabolite BMT-100948 | 29 timepoints up to Cycle 3 Day 1 (approximately 32 days) |
| Pharmacodynamics (PD) changes in the expression of Notch pathway-related genes, including but not limited to Hes1 and Deltex1, as determined by standard molecular methods | 16 timepoints up to Cycle 2 Day 16 (approximately 20 days) |
| Preliminary anti-tumor activity of BMS-986115 as measured by response evaluation criteria in solid tumors (RECIST) | Assessed by:
| Screening (within 30 days prior to Day 1), Every 8 weeks, End of Treatment or 30-Day follow-up visits (approximately 18 months) |
| Parkville |
| Victoria |
| 3050 |
| Australia |
| Local Institution | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |