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NCT05868629 | Not yet 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 (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.

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 : March 3, 2024
Estimated Primary Completion Date : October 26, 2027
Estimated Study Completion Date : February 29, 2028

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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