BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 9, 2012

Primary Completion Date

December 13, 2013

Study Completion Date

March 21, 2017

Conditions
BRAF Mutant Metastatic Melanoma
Interventions
DRUG

BKM120 Combined with Vemurafenib (PLX4032)

"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"

Trial Locations (1)

94115

University of California, San Francisco, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

University of California, San Francisco

OTHER