CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 206 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.

Search/NCT02034110
NCT02034110Phase 2Completed
CompareCT.gov

A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

Novartis Pharmaceuticals·interventional·Posted Jan 13, 2014·Updated Aug 21, 2023

In Brief

A Phase 2 clinical trial evaluating Dabrafenib and Trametinib for Cancer. Completed, enrolled 206 participants across 41 sites in 14 countries.

Detailed Summary

This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC), biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), low grade (WHO G1/G2) glioma (LGG), high grade (WHO G3/G4) glioma (HGG), non-seminomatous germ cell tumors (NSGCT) / non-germinomatous germ cell tumors (NGGCT), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL) and multiple myeloma (MM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesAustria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 13, 2014
Enrollment StartMar 12, 2014
Primary CompletionDec 10, 2021
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 12.5 years ago

Interventions

Dabrafenibdrug

A 150 mg twice daily capsule administered orally on a continuous basis.

Trametinibdrug

A 2 mg once daily tablet administered orally on a continuous basis.