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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

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 SiteFort Worth, Texas  76104
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012