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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02920697 | Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma | PHASE1 | COMPLETED | 65 | — | — | Mar 1, 2014 | Oct 22, 2018 | Jul 25, 2024 | 18 | Australia, France +6 |
The MTD is the highest drug dosage that is unlikely (\<25% posterior probability) to cause DLT in more than 33% of the treated patients in the first cycle of S 55746 treatment
Characterized by severity and seriousness of AEs, laboratory abnormalities and other safety parameters such as electrocardiogram (ECG) changes
| Arm | Type | Description |
|---|---|---|
| B-cell Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM) | EXPERIMENTAL | - |
| Chronic Lymphocytic Leukaemia (CLL) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| S 55746 | DRUG | S 55746, per os administration, from 50 to 1500 mg, once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met. |
Inclusion Criteria: * Women or men aged \>/=18 years * Patients with a measurable histologically confirmed Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Small Lymphocytic Lymphoma (SLL) and Marginal Zone Lymphoma (MZL) (Arm A), or patients with an eval...