Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RAF265 · 1 trial · 1 indication
| 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...
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RAF265 is an investigational oral small molecule developed by Novartis for locally advanced or metastatic melanoma. It has been studied in a Phase 1 clinical trial in adults with metastatic melanoma. It is not an approved therapy and remains in clinical development.
RAF265 targets BRAF and KDR. It is a small molecule inhibitor that acts on these kinases. BRAF is part of the MAP kinase signaling pathway often altered in melanoma, and KDR is a vascular endothelial growth factor receptor involved in angiogenesis.
RAF265 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical research evaluating the compound in melanoma.
RAF265 is in Phase 1 development. It has completed one Phase 1 clinical trial in patients with locally advanced or metastatic melanoma. It is investigational and has not been approved by the FDA for any indication.
RAF265 was evaluated in the Phase 1 trial NCT00304525, titled a study to evaluate RAF265, an oral drug administered to subjects with locally advanced or metastatic melanoma. The trial enrolled 104 participants across the United States and Switzerland and is completed.
No. The Phase 1 trial of RAF265 in metastatic melanoma, NCT00304525, did not use biomarker selection to enroll patients. Participants were adults 18 years and older with locally advanced or metastatic melanoma, and the study enrolled 104 patients.