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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03246074 | Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer | PHASE1 | COMPLETED | 35 | — | — | Apr 3, 2018 | Apr 3, 2023 | Oct 24, 2024 | 3 | United States |
The number of dose limiting toxicities (DLTs) at each dose level will be reported. All toxicities will be reported by type and grade using NCI CTCAE version 4.03.
The MTD will be determined as the dose level with the highest probability of having a risk of DLT in the acceptable region based on the mTPI dose-escalation design. Measured at 28 days (DLT period).
| Arm | Type | Description |
|---|---|---|
| Fostamatinib 100 mg bid and Paclitaxel | EXPERIMENTAL | Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. |
| Fostamatinib 150 mg bid and Paclitaxel | EXPERIMENTAL | Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. |
| Fostamatinib 200 mg bid and Paclitaxel | EXPERIMENTAL | Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Fostamatinib 100 mg bid and Paclitaxel | DRUG | Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2) |
| Fostamatinib 150 mg bid and Paclitaxel | DRUG | Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2) |
| Fostamatinib 200 mg bid and Paclitaxel | DRUG | Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2) |
* Inclusion Criteria 1. Patients must have histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation (via the pathology report) of the original primary tumor is required. 2. Patients must have measurable disease, acco...