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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01227889
First received: October 21, 2010
Last updated: March 28, 2013
Last verified: March 2013

October 21, 2010
March 28, 2013
December 2010
December 2011   (final data collection date for primary 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. [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01227889 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) defined as the time from randomization to death due to any cause [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • PFS, defined for subjects randomized to the DTIC treatment groups as the time to progression or death after cross-over to GSK2118436 after initial progression on DTIC. [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Overall response rate (ORR), defined as the percentage of subjects achieving either a commplete or partial tumor response. [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Duration of response, defined for those subjects who show a complete or partial tumor response, the time from first documented complete response or partial response until the first documented sign of disease progression or death due to any cause. [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Duration of response in subjects who cross-over to GSK2118436, after initial progression on DTIC [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Rate of treatment-emergent non-melanoma skin lesions in each treatment group, defined as the percentage of subjects with non-melanoma skin lesions reported [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Validation of the BRAF mutation assay. [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
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

BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Drug: GSK2118436
    150 mg twice daily
  • Drug: Dacarbazine (DTIC)
    Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression
  • Experimental: GSK2118436
    Subjects in this arm will receive GSK2118436 150 mg twice daily.
    Intervention: Drug: GSK2118436
  • Active Comparator: Dacarbazine (DTIC)
    Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks
    Intervention: Drug: Dacarbazine (DTIC)
  • Experimental: Crossover
    Subjects who initially receive DTIC will be allowed to receive GSK2118436 after initial progression.
    Intervention: Drug: GSK2118436
Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, Rutkowski P, Blank CU, Miller WH Jr, Kaempgen E, Martín-Algarra S, Karaszewska B, Mauch C, Chiarion-Sileni V, Martin AM, Swann S, Haney P, Mirakhur B, Guckert ME, Goodman V, Chapman PB. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358-65. doi: 10.1016/S0140-6736(12)60868-X. Epub 2012 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Hungary,   Ireland,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain
 
NCT01227889
113683
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2013

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