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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00726323 | A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC) | PHASE2 | COMPLETED | 74 | — | — | Jun 30, 2006 | Aug 18, 2010 | Dec 11, 2017 | 12 | United States |
Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.
| Arm | Type | Description |
|---|---|---|
| 5/9 dosing | EXPERIMENTAL | 240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days. |
| daily dosing | EXPERIMENTAL | 80 mg foretinib on a daily dosing regimen |
| Name | Type | Description |
|---|---|---|
| foretinib (formerly GSK1363089 or XL880) | DRUG | treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule |
Inclusion Criteria: * Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of \</= 2. * Adequate bone marrow reserve, hepatic, renal, and cardiovascular function. Exclusion Criteria:...