Approval Probability
TA Base Rate
Adjusted LOA
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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 small molecule being studied for the treatment of metastatic melanoma. It is administered orally and is intended for patients with locally advanced or metastatic melanoma. The drug is currently in clinical development and has not been approved by regulatory authorities.
RAF265 is a small molecule that targets RAF kinases, which are involved in cell signaling pathways that regulate cell growth and division. By inhibiting these kinases, RAF265 aims to disrupt the signaling that drives the growth of melanoma cells. This mechanism is being evaluated in clinical trials for metastatic melanoma.
RAF265 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and efficacy of RAF265 in patients with metastatic melanoma.
RAF265 is in Phase 1 clinical development. It has completed a Phase 1 trial that enrolled 104 participants with locally advanced or metastatic melanoma. The drug is still investigational and has not received FDA approval. Further clinical studies would be needed to establish its safety and efficacy.
RAF265 has been studied in one clinical trial with the identifier NCT00304525. This Phase 1 study evaluated the drug in subjects with locally advanced or metastatic melanoma and was conducted in the United States and Switzerland. The trial has been completed, and the drug is not currently in active clinical trials.
RAF265 is not known to have alternative names. It is a distinct investigational compound developed by Novartis. No other names for this drug have been identified in the available information.