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

NCT01512251 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-08-17

Study results available
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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.

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-09
Primary Completion
2013-12-13
Completion
2017-03-21

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512251 on ClinicalTrials.gov