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Trial 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
NCT ID:
NCT05868629
Condition:
Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
BRAF
v-raf murine sarcoma viral oncogene homolog B1
dabrafenib
trametinib
tumor agnostic
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-investigational
Description:
Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e.
solid formulation or liquid formulation, if approved and commercially available locally)
per local guidance or patient access program
Arm group label:
dabrafenib plus trametinib
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.
Criteria for eligibility:
Study pop:
Study participants diagnosed with a rare BRAF V600E mutation-positive unresectable or
metastatic solid tumor, 6 years and older excluding patients with melanoma, Non-Small
Cell Lung Cancer, Colorectal Cancer, Anaplastic Thyroid Cancer, Biliary Tract Cancer and
glioma, who will be treated with dabrafenib and trametinib.
Sampling method:
Non-Probability Sample
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;
Gender:
All
Minimum age:
6 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke Clinical Research Institute .
Address:
City:
Durham
Zip:
27704
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emily Bolch
Email:
emily.bolch@duke.edu
Investigator:
Last name:
John Strickler
Email:
Principal Investigator
Start date:
February 6, 2024
Completion date:
February 29, 2028
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05868629
