Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pimasertib once daily · 1 trial · 1 indication
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 | - |
| 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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Pimasertib is an investigational small molecule being studied for the treatment of ovarian cancer. It is administered once daily and is currently in Phase 2 clinical development. The drug has been evaluated in a completed clinical trial involving 65 female participants aged 18 years and older.
Pimasertib is being developed by Sanofi, a company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this investigational drug for the treatment of ovarian cancer.
Pimasertib is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial for ovarian cancer has been completed, but the drug remains under investigation.
Pimasertib has been studied in a completed Phase 2 clinical trial identified as NCT01936363. This trial, titled "Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer," enrolled 65 participants and was conducted in the United States, Australia, Belgium, Canada, France, Poland, and Spain.
No, Pimasertib is not the same as SAR245409. In the clinical trial NCT01936363, Pimasertib was studied in combination with SAR245409 or placebo. These are two distinct investigational drugs being evaluated together for the treatment of ovarian cancer.