At a glance
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A Phase 1/2 Trial of BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma (Novartis Study Number CBKM120ZUS21T)
In Brief
A Phase 2 clinical trial evaluating BKM120 Combined with Vemurafenib (PLX4032) for BRAF Mutant Metastatic Melanoma. Completed, enrolled 8 participants across 1 site.
Detailed Summary
This is a phase 1/2 clinical trial with the goal of determining whether the addition of the investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free survival in patients with BRAFV600E/K mutant melanoma.
Study Details
Timeline
Interventions
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