DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorCancer Research UK

About this trial

This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.

Investigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.

This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

Eligibility criteria

Qualifiers

None

Disqualifiers

Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.

Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.

Male patients must refrain from donating sperm for the same period.

Colorectal cancer in adult (≥18 years) patients;

Trial design

Treatments tested in this trial

  • Dabrafenib
  • Trametinib

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

27
Belfast City HospitalBT9 7AB, Belfast United Kingdom
Birmingham Children's HospitalB4 6NH, Birmingham United Kingdom
University Hospital BirminghamB15 2TT, Birmingham United Kingdom
Bristol Haematology and Oncology CentreBS2 8ED, Bristol United Kingdom

Sponsors and collaborators

Cancer Research UK

Lead sponsor

University of Manchester

Collaborator

University of Birmingham

Collaborator

Novartis Pharmaceuticals UK Limited

Collaborator

Royal Marsden Hospital NHS Foundation Trust & The Institute of Cancer Research

Collaborator