RECRUITING

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Description

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.

Conditions

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
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Related Conditions:

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Study Overview

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Study Details

Study overview

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Condition
Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Durham

Duke Clinical Research Institute ., Durham, North Carolina, United States, 27704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
  • * At least 1 measurable lesion as defined by RECIST v1.1 per local review;
  • * Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
  • * Ability to provide scans for central imaging review
  • * Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
  • * Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2028-02-29