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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00304525 | A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma | PHASE1 | COMPLETED | 104 | — | — | Apr 1, 2006 | Nov 1, 2013 | Dec 19, 2020 | 11 | United States, Switzerland |
| Arm | Type | Description |
|---|---|---|
| RAF265 - Arm 1 | EXPERIMENTAL | Patients received 10mg RAF265 as a once weekly dose until progressive disease was confirmed. |
| RAF265 - Arm 2 | EXPERIMENTAL | RAF265 is given as a single "PK run-in" dose, a single loading dose on day 1 of cycle 1, followed by once daily maintenance doses. |
| RAF265 - Arm 3 | EXPERIMENTAL | Patients were treated with once weekly dosing of RAF265 |
| RAF265 - Arm 4 | EXPERIMENTAL | Patients with locally advanced or metastatic melanoma will utilize a dose close to or at the MTD/RPTD of the liquid formulation that was determined in Arm 2. |
| RAF265 - Arm 5 | EXPERIMENTAL | RAF265 was administered as a continuous dose for 2 weeks followed by a dose holiday of 1 week. |
| Name | Type | Description |
|---|---|---|
| RAF265 | DRUG | A liquid nonaqueous oral formulation. Switched to a tablet formulations with was 60% bioavailable, relative to the liquid at 50mg dose. The liquid dose will be multiplied by a factor of 1.67 to achieve a comparable tablet dose. Tablets are available in 10mg and 50mg strengths. |
Inclusion Criteria: 1. Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV 2. Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan 3. ECOG perform...