Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)

Sponsor
GlaxoSmithKline
Study ID
NCT01928940
Phase
PHASE2
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).

Key Dates

Start date
Aug 15, 2013
Status verified
Jul 2017
Primary completion
Sep 18, 2014
Completion
Jul 4, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: dabrafenib + trametinib
    Combination therapy of dabrafenib and trametinib

Primary Outcome Measure

Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) [ Time Frame: From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year) ]

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