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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01403636 | A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia | PHASE2 | COMPLETED | 167 | — | — | Oct 1, 2011 | Sep 1, 2014 | Mar 17, 2016 | 30 | United States, Australia +4 |
| Arm | Type | Description |
|---|---|---|
| mantle cell | EXPERIMENTAL | 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose |
| follicular lymphoma | EXPERIMENTAL | 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose |
| CLL/SLL | EXPERIMENTAL | 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose |
| Diffuse large B cell lymphoma | EXPERIMENTAL | 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose |
| Name | Type | Description |
|---|---|---|
| SAR245409 | DRUG | Pharmaceutical form:capsule Route of administration: oral |
Inclusion criteria: * Tissue from an archived or fresh tumor sample * A peripheral blood buffy coat sample is required for CLL/SLL. * Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma * Patient \> or = 18 yea...