drugset / Trial / NCT02510001
MEK and MET Inhibition in Colorectal Cancer
Phase 1
Completed
82 enrolled
University of Oxford
Array BioPharma · collabBeaumont Hospital · collabBelfast Health and Social Care Trust · collabEuropean Commission · collabEuropean Georges Pompidou Hospital · collabHospital Vall d'Hebron · collabOxford University Hospitals NHS Trust · collabPfizer · collabQueen's University, Belfast · collabSaint Antoine University Hospital · collabUniversity Hospital, Antwerp · collabUniversity of Paris 5 - Rene Descartes · collabUniversity of Turin, Italy · collabVelindre NHS Trust · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This trial is designed to try two new cancer drugs together for the first time. The investigators think that they might be effective in some types of bowel cancer. The first part of the trial will see what doses of the two drugs can safely be given together. Once the investigators have identified a suitable dose combination they will look at how effective treatment is in bowel cancers where either the RAS gene is mutated, or MET is over-active. In the trial the investigators will look at samples of blood, skin and tumour to check the drugs are working in the way expected. The trial will take place in three sites in the UK and 5 sites in Europe. The trial is funded as part of the European commission's FP7 program.
Timeline
- Start
- 2014-11
- Primary completion
- 2018-12-03
- Completion
- 2018-12-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | 30 mg | — |
| Subject | Binimetinib | Small molecule | 45 mg | — |
| Subject | Crizotinib | Small molecule | 200 mg | — |
| Subject | Crizotinib | Small molecule | 250 mg | — |
| Subject | Mirdametinib | Small molecule | 2 mg | — |
| Subject | Mirdametinib | Small molecule | 4 mg | — |
| Subject | Mirdametinib | Small molecule | 8 mg | — |