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

NCT02974803 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-08-20

Study results available
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Summary

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

Conditions

Interventions

DRUG

Dabrafenib

Dabrafenib 150 mg twice a day until progression or unaccepted toxicity.

DRUG

Trametinib

Trametinib 2 mg once daily until progression or unaccepted toxicity.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Arjun Sahgal · Odette Cancer Centre, Toronto, ON Canada

  • Teresa Petrella · Odette Cancer Centre, Toronto, ON Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2020-07-29
Completion
2020-07-29

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02974803 on ClinicalTrials.gov