A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by GlaxoSmithKline.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01153763
First received: May 27, 2010
Last updated: June 21, 2012
Last verified: April 2012
  Purpose

BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.


Condition Intervention Phase
Melanoma
Drug: GSK2118436
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Overall response rate in V600E mutant melanoma subjects, which is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per RECIST 1.1 criteria. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival between the first dose and the earliest date of disease progression or death due to any cause. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Duration of response for the subset of subjects with confirmed complete response (CR) or partial response (PR) from first documented evidence of CR or PR until time of first documented disease progression or death due to any cause. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Overall survival from first dose until death due to any cause. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Overall response rate in patients with V600K mutant melanoma. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All patients
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Drug: GSK2118436
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must have histologically confirmed cutaneous metastatic melanoma (Stage IV) that is BRAF mutation-positive (V600 E/K) as determined via central testing with a BRAF mutation assay.
  • Is treatment naive or has received prior treatment for metastatic melanoma.
  • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • 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 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Adequate organ function.

Exclusion Criteria:

  • Previous treatment with a BRAF or MEK inhibitor.
  • Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
  • A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
  • History or evidence of brain metastases on MRI or head CT if MRI is not able to be performed.
  • History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Certain cardiac abnormalities.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153763

Locations
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Los Angeles, California, United States, 90095
GSK Investigational Site
San Francisco, California, United States, 94115
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Australia, New South Wales
GSK Investigational Site
Newcastle, New South Wales, Australia, 2300
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
France
GSK Investigational Site
Boulogne-Billancourt, France, 92100
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Marseille Cedex 5, France, 13385
GSK Investigational Site
Montpellier, France, 34295
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Villejuif, France, 94805
Germany
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Berlin, Germany, 10117
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Padova, Veneto, Italy, 35128
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153763     History of Changes
Other Study ID Numbers: 113710
Study First Received: May 27, 2010
Last Updated: June 21, 2012
Health Authority: Italy: Agenzia Italiana del Farmaco
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Française de Sécurité Sanitaire des Produits de Santé
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Metastatic melanoma
BRAF mutant
Melanoma
BRAF mutant metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 14, 2014