At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
dabrafenib +1 moredrug
Likely dose
dabrafenib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Japanese Open-label Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of GSK2118436 and GSK1120212 Combination Therapy 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).
In Brief
A Phase 2 clinical trial evaluating dabrafenib and trametinib for Solid Tumours. Completed, enrolled 12 participants across 2 sites.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumours
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionSep 2014
Study CompletionJul 2016
TodayJul 2026
First PostedAug 27, 2013
Enrollment StartAug 15, 2013
Primary CompletionSep 18, 2014
Study CompletionJul 4, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.8 years ago
Interventions
dabrafenibdrug
150 mg twice daily
trametinibdrug
2 mg once daily