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NCT05868629 | RECRUITING | Rare Unresectable or Metastatic BRAF V600E Mutation-positive 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
Sponsor:

Novartis Pharmaceuticals

Brief Summary:

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 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.

Condition or disease

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Intervention/treatment

Non-investigational

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Actual Study Start Date : 2024-02-06
Estimated Primary Completion Date : 2028-03-03
Estimated Study Completion Date : 2028-03-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Year to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
Exclusion Criteria
  • * 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;
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Location Details

NCT05868629

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Lundquist Inst BioMed at Harbor

Torrance, California, United States, 90509-2910

RECRUITING

United States, District of Columbia

Johns Hopkins University

Washington D.C., District of Columbia, United States, 20016

RECRUITING

United States, North Carolina

Duke Clinical Research Institute

Durham, North Carolina, United States, 27704

RECRUITING

United States, Ohio

Oncology Hematology Care Inc

Cincinnati, Ohio, United States, 45242

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

El Paso Texas Oncology

The Pass, Texas, United States, 79902