Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BKM120 Combined with Vemurafenib · 1 trial · 1 indication
RP2D determined by maximum tolerated dose (MTD), post-dose-limiting toxicity (DLT) period toxicity, and pharmacokinetic data
6 month progression-free survival rate (PFS6) determined by tumor assessments, clinical tests and laboratory tests
| Arm | Type | Description |
|---|---|---|
| No Previous Treatment | OTHER | 150 mg oral dabrafenib twice a day until disease progression, death, or unacceptable adverse events. |
| Name | Type | Description |
|---|---|---|
| BKM120 Combined with Vemurafenib (PLX4032) | DRUG | Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D) Dose Level -1: BKM120 60 mg daily, Vemurafenib 480 mg bid Dose Level 1: BKM120 60 mg daily, Vemurafenib 720 mg bid Dose Level 2: BKM120 80 mg daiy, Vemurafenib 720 mg bid Dose Level 3: BKM120 100 mg daiy, Vemurafenib 720 mg bid Dose Level 4: BKM120 100 mg daiy, Vemurafenib 960 mg bid Phase II is a single-stage, single arm prospective trial: patients will receive BKM120 and vemurafenib at the RP2D |
Inclusion Criteria 1. Histologically or cytologically confirmed diagnosis of unresectable stage III and stage IV melanoma 2. BRAFV600E or BRAFV600K mutation-positive 3. Age \>= 18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 5. Patients must have at least one site of ...
BKM120 Combined with Vemurafenib is an investigational combination therapy being studied for the treatment of BRAF mutant metastatic melanoma. It is a small molecule regimen developed by Novartis AG. The combination is intended for patients with BRAF-mutated advanced melanoma, and it is currently in clinical development.
BKM120 Combined with Vemurafenib targets the BRAF V600E/K mutation in metastatic melanoma. Vemurafenib is a BRAF inhibitor that blocks the mutated BRAF protein, while BKM120 is a PI3K inhibitor. Together, they aim to inhibit signaling pathways that drive tumor growth in BRAF-mutant melanoma.
BKM120 Combined with Vemurafenib is developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate this combination therapy for patients with BRAF mutant metastatic melanoma.
BKM120 Combined with Vemurafenib is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of BRAF mutant metastatic melanoma.
BKM120 Combined with Vemurafenib has been studied in one clinical trial with the identifier NCT01512251. This Phase 1 trial, titled "BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma," was conducted in the United States and has been completed. The trial enrolled 8 participants with BRAF mutant metastatic melanoma.
BKM120 Combined with Vemurafenib is not the same as PLX4032. PLX4032 is another name for vemurafenib, which is one component of the combination. The combination therapy includes both BKM120 and vemurafenib (PLX4032), and it is being studied as a dual-agent regimen for BRAF-mutant melanoma.