Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR125844 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| SAR125844 | EXPERIMENTAL | Given intravenously weekly at the dose of 570 mg/m\^2 for at least 18 weeks |
| Dose escalation | EXPERIMENTAL | SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m\^2), if the highest cleared dose in TED11449 is \>340 mg/m\^2. |
| Name | Type | Description |
|---|---|---|
| SAR125844 | DRUG | Pharmaceutical form:Concentrate for solution Route of administration: intravenous |
Inclusion criteria: Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Exclusion criteria: Patient less than...
SAR125844 is an investigational small molecule being studied for the treatment of malignant solid tumors and other malignant neoplasms. It is administered as a slow intravenous infusion to adult patients with advanced disease. The drug is in clinical development for oncology indications.
SAR125844 is being developed by Sanofi, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol SNY. Sanofi has sponsored clinical trials of SAR125844 in patients with advanced malignant solid tumors.
SAR125844 has completed Phase 1 clinical trials in patients with advanced malignant solid tumors. A Phase 2 study in NSCLC patients with MET amplification was also completed, though it enrolled only one participant. The drug remains investigational and is not approved for any use.
SAR125844 has been studied in two completed Phase 1 trials: NCT01391533, which enrolled 72 adults with advanced malignant solid tumors in the United States, France, Italy, and Spain, and NCT01657214, which enrolled 70 Asian patients with malignant neoplasms in Japan and South Korea. A Phase 2 trial, NCT02435121, was also completed.
SAR125844 is not FDA approved. It is an investigational drug that has completed early-stage clinical trials, including Phase 1 studies in patients with advanced malignant solid tumors. No approval status has been granted, and the drug remains in clinical development.
SAR125844 is administered as a slow intravenous infusion. In clinical trials, it was given as a single agent to adult patients with advanced malignant solid tumors. The dosing schedule and infusion duration were evaluated in Phase 1 dose-escalation studies.