Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR245409 · 3 trials · 5 indications
| 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 |
| Once daily dosing | EXPERIMENTAL | escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
| Twice daily dosing | EXPERIMENTAL | escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
| SAR245409 + rituximab | EXPERIMENTAL | Subjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously |
| SAR245409 + rituximab + bendamustine (iNHL, MCL) | EXPERIMENTAL | Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously. |
| SAR245409 + rituximab+ bendamustine (CLL) | EXPERIMENTAL | Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine and rituximab intravenously |
| 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...
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SAR245409 is an investigational small molecule being studied for the treatment of certain cancers, including lymphoma, indolent non-Hodgkin lymphoma, and other malignant neoplasms. It has been evaluated in clinical trials involving patients with lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, and solid tumors.
SAR245409 is being developed by Sanofi, a global biopharmaceutical company. Sanofi has sponsored clinical trials to evaluate the safety and efficacy of SAR245409 in patients with various types of cancer.
SAR245409 has been studied in Phase 1 and Phase 2 clinical trials. The trials have been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities for commercial use.
SAR245409 has been studied in three completed clinical trials. NCT01403636 was a Phase 2 study in patients with lymphoma. NCT01410513 was a Phase 1 study combining SAR245409 with rituximab or bendamustine plus rituximab in patients with indolent lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia. NCT01596270 was a Phase 1 study in patients with solid tumors or lymphoma.
SAR245409 is a distinct investigational compound developed by Sanofi. It has been tested alone and in combination with other therapies, such as rituximab and bendamustine, in clinical trials for various hematologic malignancies and solid tumors.