Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01120457 | First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects With Acute Myelogenous Leukemia and Selected B-cell Cancers | PHASE1 | COMPLETED | 96 | — | — | Aug 1, 2010 | Nov 1, 2014 | Mar 6, 2015 | 11 | United States |
Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities
| Arm | Type | Description |
|---|---|---|
| Arm 1: Dose Escalation and Expansion cohort (AML Patients) | EXPERIMENTAL | Dose Escalation: BMS-936564 0.3-10 mg/kg solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle) Dose Expansion: BMS-936564 maximum tolerated dose (MTD) based on dose escalation, solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle) |
| Arm 2: Dose Expansion cohort (DLBCL Patient) | EXPERIMENTAL | BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle) |
| Arm 3: Dose Expansion cohort (CLL Patient) | EXPERIMENTAL | BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle) |
| Arm 4: Dose Expansion cohort (FL Patient) | EXPERIMENTAL | BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle) |
| Name | Type | Description |
|---|---|---|
| BMS-936564 (Anti-CXCR4) | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: A. Common to All Indications: * Life expectancy at least 12 weeks * ECOG Performance Status of 0-2 B. For Acute myelogenous leukemia (AML) Subjects: * First Relapse and pri...