Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01936363 | Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer | PHASE2 | COMPLETED | 65 | — | — | Sep 30, 2013 | Nov 30, 2017 | Dec 12, 2018 | 34 | United States, Australia +5 |
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...