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

May 27, 2010
June 21, 2012
August 2010
July 2011   (final data collection date for primary outcome measure)
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 ]
Overall response rate for the duration that the patient is on study, 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 ]
Complete list of historical versions of study NCT01153763 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 1-2 years. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Drug: GSK2118436
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
All patients
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Intervention: Drug: GSK2118436
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
92
August 2012
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   Italy
 
NCT01153763
113710
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP