A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma
Inclusion Criteria:
- Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable)
or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using
the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011).
The assay will be conducted by a central reference laboratory. Subjects with ocular
or mucosal melanoma are not eligible.
- The subject must have a radiologically 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 counts
Exclusion Criteria:
- Prior treatment with a BRAF or a MEK inhibitor
- Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV
(metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed.
(Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)
- The subject has received major surgery or certain tyes of cancer therapy with 21 days
of starting treatment
- Current use of prohibited medication listed in the protocol
- Left ventricular ejection fraction less than the lower limit of normal
- Uncontrolled blood pressurl
- History or current evidence of retinal vein occlusion or central serous retinopathy
- Brain metastases unless previously treated with surgery or stereotactic radiosurgery
and the disease has been stable for at least 12 weeks
- The subject is pregnant or nursing
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Description:
Progression-free survival defined as the time from randomization until the earliest date of disease progression or death due to any cause
Outcome Time Frame:
Up to 13 months
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Australia: Human Research Ethics Committee
Study ID:
115306
NCT ID:
NCT01584648
Start Date:
May 2012
Completion Date:
January 2015
Related Keywords:
- Melanoma
- Randomized study
- combination therapy
- BRAF inhibitor
- GSK1120212
- BRAF V600E/K mutation-positive cutaneous melanoma
- trametinib
- GSK2118436
- MEK inhibitor
- Phase III
- dabrafenib
- Melanoma
Name | Location |
|---|---|
| GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Indianapolis, Indiana 46260 |
| GSK Investigational Site | Springfield, Massachusetts 01107 |
| GSK Investigational Site | Akron, Ohio 44304 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Germantown, Tennessee 38138 |
| GSK Investigational Site | New York, New York 10021 |
