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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03648489 | Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) | PHASE2 | COMPLETED | 134 | — | — | Sep 21, 2018 | Nov 30, 2023 | Sep 20, 2024 | 15 | Germany, United Kingdom |
PFS (as assessed by RECIST v1.1), defined as time from study entry to first evidence of disease progression or death due to any cause
| Arm | Type | Description |
|---|---|---|
| Arm 1: Weekly paclitaxel alone | ACTIVE_COMPARATOR | Paclitaxel, concentrate for solution for infusion 80mg per metre squared on day 1, 8 and 15 of a 28 day cycle. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria |
| Arm 2: Weekly paclitaxel plus TAK228 | EXPERIMENTAL | Paclitaxel, concentrate for solution for infusion 80mg per metre squared on day 1, 8 and 15 of a 28 day cycle. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria TAK228, oral capsule 4mg on days 2-4, 9-11, 16-18 and 23-25 of a 28 day cycle i.e. in concurrence with paclitaxel. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Please refer to arm/group description |
| TAK228 | DRUG | Please refer to arm/group description |
Inclusion Criteria: * Signed and dated written informed consent prior to admission to the study and initiation of any study procedures in accordance with ICH-GCP guidelines and to the local legislation * Females ≥ 18 years of age * Pathological diagnosis of ovarian, fallopian tube or primary perito...