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A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma


Inclusion Criteria:



- Adults at least 18 years of age

- Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF
mutation positive (V600E)

- Is treatment naive for advanced (unresectable) or metastatic melanoma, with the
exception of Interleukin 2 (IL-2) which is allowed.

- Has measurable disease according to RECIST 1.1 criteria.

- Women of child-bearing potential must have a negative pregnancy test within 14 days
prior to the first dose of study treatment.

- Women with reproductive potential must be willing to practice acceptable methods of
birth control during the study and for up to 4 weeks after the last dose of study
medication.

- Men with reproductive potential must be willing to practice acceptable methods of
birth control during the study and for up to 16 weeks after the last dose of study
medication.

- Must have adequate organ function.

- Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Exclusion Criteria:

- Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy,
biologic therapy or surgery).

- Evidence of active central nervous system (CNS) disease.

- Previous treatment for metastatic melanoma, including treatment with BRAF or MEK
inhibitor.

- A history of other malignancy. Subjects who have been disease-free for 5 years or
subjects with a history of complete resected non-melanoma skin cancer or successfully
treated in situ carcinoma are eligible.

- History of Human Immunodeficiency Virus (HIV) infection.

- Certain cardiac abnormalities

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS), defined as the time from randomization until the first date of either objective disease progression or death due to any cause.

Outcome Time Frame:

approximately 2 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Italy: AIFA - Italian Ministry of Health

Study ID:

113683

NCT ID:

NCT01227889

Start Date:

December 2010

Completion Date:

June 2013

Related Keywords:

  • Cancer
  • Metastatic melanoma
  • melanoma
  • BRAF mutant
  • Advanced melanoma
  • Melanoma

Name

Location

GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Royal Oak, Michigan  48073
GSK Investigational Site New York, New York  10021
GSK Investigational Site Birmingham, Alabama  35209