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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00981240 | Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes | PHASE1 | COMPLETED | 30 | — | — | Sep 1, 2009 | Feb 1, 2012 | Mar 27, 2012 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Cohorts of 3 to 6 patients will be included at each dose level. The starting dose is 1.2mg/m2/day. The dose will be increased in new cohorts of patients according to toxicities observed during the first 4-week treatment period. The escalation process will continue until the MTD is determined. Additional 15 patients will be included at the MTD. |
| Name | Type | Description |
|---|---|---|
| SAR103168 | DRUG | Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous infusion |
Inclusion Criteria: * Patients with refractory/relapsed acute leukemias or high-risk myelodysplastic syndromes with no curative option available including any of the following: * Patients with de novo or secondary acute myelogenous leukemia (AML) (except acute promyelocytic leukemia), meeting on...