drugset / Trial / NCT03352947
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
Phase 2
Completed
79 enrolled
Cambridge University Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom · collabOxford University Hospitals NHS Trust · collabUniversity of Oxford · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This feasibility study aims to determine if intermittent dosing is deliverable, based on patient and professional willingness to take part in a randomised trial evaluating less rather than the standard durations of treatment. The trial will evaluate treatment compliance, Progression Free Survival and Quality of Life, to inform whether a subsequent definitive trial is justified and how it should be designed.
Timeline
- Start
- 2017-11-03
- Primary completion
- 2020-03-31
- Completion
- 2020-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabrafenib | Small molecule | 150 mg | Oral |
| Subject | Trametinib | Small molecule | 2 mg | Oral |