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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01223027 | Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma | PHASE3 | COMPLETED | 564 | — | — | Mar 1, 2011 | Jun 1, 2014 | Dec 7, 2015 | 199 | United States, Argentina +25 |
Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.
| Arm | Type | Description |
|---|---|---|
| Dovitinib + best supportive care (BSC) | EXPERIMENTAL | Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule. |
| Sorafenib + BSC | ACTIVE_COMPARATOR | Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily. |
| Name | Type | Description |
|---|---|---|
| Dovitinib | DRUG | Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language. |
| Sorafenib | DRUG | Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice. |
Inclusion Criteria: * Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell * Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy ...