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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


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

Thank you

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 SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021