West Cancer Center

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ADVANCED SOLID TUMORS; Phase 1; BRAF mutation; roll-over; "114144"

A rollover study to provide continued treatment with GSK2118436 to subjects with BRAF mutation-positive tumors

Title

GSK 114144

Study Title

A rollover study to provide continued treatment with GSK2118436 to subjects with BRAF mutation-positive tumors

Site Link

NCT01231594

Malignancy

z- melanoma, gastric, colorectal, breast, lung, prostate, pancreas, biliary, head and neck, kidney, bladder, sarcoma, brain

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

Any, following prior participation on GSK BRF study

Investigational Agent

Dabrafenib

Drug Class

BRAF inhibitor

Jason Chandler, MD

Sponsor

GlaxoSmithKline

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01231594

Key Eligibility Criteria Details

Currently participating in a trial of dabrafenib
No evidence of progressive disease on dabrafenib
No permanentdiscontinuation of dabrafenib for toxicity
No unresolved toxicity of grade 2 or higher
LVEF >50% at transition to this study
QTc <480 ms
No CHF

Objective

Primary- safety and tolerability

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

BRAF mutation

Dosing Frequency

As per parent study

Control Agents

N/A

Study Protocol

Randomized