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SAR245409 · 4 trials · 6 indications
Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (\<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Pimasertib (once daily) plus SAR245409 | EXPERIMENTAL | - |
| Pimasertib (twice daily) plus SAR245409 placebo | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| Pimasertib once daily | DRUG | Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| Pimasertib placebo | DRUG | Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| SAR245409 placebo | DRUG | Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| SAR245409 | DRUG | SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| Pimasertib twice daily | DRUG | Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
Inclusion Criteria: * The female participant had a diagnosis of one of the following: a) low-grade serous ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline ovarian or peritoneal tu...
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SAR245409 is an investigational small molecule developed by Sanofi for oncology indications. It has been studied in indolent non-Hodgkin lymphoma, lymphoma, malignant neoplasms, and ovarian cancer. It is also described as a PI3K and mTOR inhibitor. Development has remained in the clinical stage, with trials conducted in Phase 1 and Phase 2 settings.
SAR245409 has been studied in indolent non-Hodgkin lymphoma, lymphoma, malignant neoplasms, and ovarian cancer. Clinical trials enrolled patients with these conditions, including a Phase 2 study in ovarian cancer and Phase 1 studies in solid tumors or lymphoma. It is an investigational agent and is not an approved treatment.
SAR245409 targets PI3K and mTOR, as reflected in its alternative name, SAR245409 (PI3K and mTOR inhibitor). Both are components of signaling pathways involved in cell growth and proliferation. This dual inhibition profile was the basis for studying the small molecule across lymphoma, leukemia, and solid tumor indications.
SAR245409 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical trials evaluating the compound in lymphoma, leukemia, and solid tumor indications. The drug remains an investigational asset within Sanofi's oncology pipeline.
SAR245409 has been evaluated in Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved for any indication. The completed studies include a Phase 1 pharmacokinetics trial in solid tumors or lymphoma and Phase 2 studies in lymphoma and ovarian cancer.
SAR245409 has been studied in completed trials including NCT01936363, a Phase 2 trial of pimasertib with SAR245409 or placebo in ovarian cancer; NCT01596270, a Phase 1 safety and pharmacokinetics study in solid tumors or lymphoma; NCT01410513, a Phase 1 combination study with rituximab or bendamustine plus rituximab in indolent lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia; and NCT01403636, a Phase 2 study in lymphoma or leukemia.