Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MSC1936369B (pimasertib)
MSC1936369B · 1 trial · 6 indications
DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (\<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of \> 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption \> 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.
| Arm | Type | Description |
|---|---|---|
| MSC1936369B and SAR245409 once daily | EXPERIMENTAL | - |
| MSC1936369B and SAR245409 twice daily | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MSC1936369B (pimasertib) | DRUG | MSC1936369B (pimasertib) single dose capsule was administered at dose of 15 milligram (mg), 30 mg, 60 mg, 90 mg orally in successive 21-day cycles.Dose escalation was proceeded until Maximum Tolerated Dose (MTD) was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohorts enrolled subjects with Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Melanoma, and Colorectal Cancer. |
| SAR245409 (PI3K and mTOR inhibitor) | DRUG | SAR245409 (PI3K and mTOR inhibitor) capsule was administered orally at a dose of 30 mg, 50 mg, 70 mg and 90 mg in successive 21-day cycles. Dose escalation was proceeded until MTD was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohort enrolled subjects with Breast Cancer, NSCLC, Melanoma, and Colorectal Cancer. |
Inclusion Criteria: * Subject with advanced solid tumors for which there is no approved therapy: * Advanced solid tumor with diagnosed alteration in one or more of the following genes (PTEN, BRAF, KRAS, NRAS, PI3KCA, ErbB1, ErbB2, MET, RET, c-KIT, GNAQ, GNA11 and/or * A histologically or cytol...
MSC1936369B is an investigational small molecule developed by Sanofi for locally advanced solid tumors. It is also known as pimasertib. It has been studied in a Phase 1 clinical trial in adults with locally advanced or metastatic solid tumors, including breast cancer, non small cell lung cancer, melanoma, and colorectal cancer.
MSC1936369B has been studied for the treatment of locally advanced or metastatic solid tumors. The Phase 1 trial enrolled patients with solid tumors including breast cancer, non small cell lung cancer, melanoma, and colorectal cancer. It is not approved for any indication and remains investigational.
MSC1936369B is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 1 clinical trial evaluating the drug in patients with locally advanced or metastatic solid tumors.
MSC1936369B is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for any indication.
MSC1936369B was evaluated in the completed Phase 1 trial NCT01390818, titled Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors. The trial enrolled 146 adults across the United States, Italy, and Spain and included patients with solid tumors, breast cancer, non small cell lung cancer, melanoma, and colorectal cancer.
Yes, MSC1936369B is also known as pimasertib. Both names refer to the same investigational small molecule developed by Sanofi for locally advanced solid tumors. The alternative name pimasertib is used in scientific literature and trial descriptions.