An Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in BRAF Mutation-positive Melanoma Subjects Previously Treated With or Without a BRAF Inhibitor
18 Years
N/A
Both
Cancer
Trial Information
An Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in BRAF Mutation-positive Melanoma Subjects Previously Treated With or Without a BRAF Inhibitor
Inclusion Criteria:
- Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF
inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior
chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
- Documented positive BRAF mutation (V600E, V600K, or V600D).
- Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to
enrollment.
- The subject must have a radiographically measurable tumor.
- The subject is able to carry out daily life activities without significant difficulty
(ECOG performance status score of 0 or 1).
- Able to swallow and retain oral medication.
- Sexually active subjects must use acceptable methods of contraception during the
course of the study.
- Adequate organ system function and blood cell counts.
Exclusion Criteria:
- The subject has had major surgery or received certain types of cancer therapy within
21 days before starting the study.
- Previous treatment with a MEK inhibitor.
- Current use of a prohibited medication listed in the protocol.
- Uncontrolled glaucoma.
- Brain metastasis, unless previously treated with surgery or stereotactic
radiosurgery, and the disease has been stable for at least 2 months prior to
enrollment.
- Current severe or uncontrolled systemic disease.
- History of clinically significant heart, lung, or eye/vision problems.
- Significant unresolved side effects from previous anti-cancer therapy.
- The subject is pregnant or breastfeeding.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with best confirmed response
Outcome Description:
Best confirmed response was assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Best response was measured either as a complete response (CR), defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters (mm), or a partial response (PR), defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met.
Outcome Time Frame:
From Baseline (Day 1) until the time of the first documented evidence of a confirmed complete response or partial response (up to approximately 25 weeks)
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
113583
NCT ID:
NCT01037127
Start Date:
December 2009
Completion Date:
January 2013
Related Keywords:
- Cancer
- GSK1120212
- BRAF Inhibitor
- melanoma
- MEK Inhibitor
- Melanoma
Name | Location |
|---|---|
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Germantown, Tennessee 38138 |
| GSK Investigational Site | New York, New York 10021 |
| GSK Investigational Site | Aurora, Colorado 80012 |
