Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Sponsor
Canadian Cancer Trials Group
Study ID
NCT02974803
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Dabrafenib 150 mg twice a day until progression or unaccepted toxicity.
  • Trametinib — DRUG
    Trametinib 2 mg once daily until progression or unaccepted toxicity.

Study Details

Dabrafenib and trametinib are drugs that are usually given for the treatment of melanoma. Combinations of dabrafenib and trametinib have also been studied and when used together have shown to increase tumour shrinkage in animals compared to either drug alone. Dabrafenib and trametinib have also shown potential to penetrate the blood-brain-barrier when given together and have an effect on brain metastases. Giving these drugs at the same time and then giving brain stereotactic radiosurgery (SRS) may also be preferred in patients with brain metastases

Key Dates

Start date
Feb 9, 2018
Status verified
Jul 2021
Primary completion
Jul 29, 2020
Completion
Jul 29, 2020

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib and Trametinib
    Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously

Primary Outcome Measure

Intracranial Objective Response Rate [ Time Frame: 24 months ]

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