Dabrafenib
Clinical Trials Overview
7 trials found
About Dabrafenib
Dabrafenib is a selective BRAF kinase inhibitor used in the treatment of metastatic colorectal cancer harboring BRAF V600E mutations. This targeted therapy is employed in combination regimens with other agents such as anti-EGFR antibodies (cetuximab or panitumumab) and chemotherapy backbones like FOLFOX for patients with advanced disease. Dabrafenib specifically addresses the therapeutic challenge posed by BRAF-mutated colorectal cancers, which represent approximately 8-15% of metastatic cases and historically demonstrate poor response to standard treatments.
Category
Targeted Therapy
Brand Name
Tafinlar
Mechanism
Dabrafenib selectively inhibits mutant BRAF V600E kinase, blocking aberrant MAPK pathway signaling that drives tumor cell proliferation and survival. By targeting this specific oncogenic mutation, the drug disrupts the downstream cascade of cellular signals that promote cancer growth and metastasis.
Efficacy Data by Mutation
Response rates and survival outcomes by patient molecular profile
BRAF V600E
Level 2A
21%
ORR
4.2m
PFS
13.5m
OS
n=37
Sample
BRAF V600E
Level 2B
12%
ORR
3.5m
PFS
9.1m
OS
n=43
Sample
BRAF V600E
Level 2B
12%
ORR
3.5m
PFS
9.1m
OS
n=43
Sample
7
Total Trials
2
Recruiting
1
Active
3
Completed
6,883
Total Enrollment
18
Countries
med_trials_trend_title
Number of trials started per year
med_trials_trend_up
med_trials_active_sites
Recruiting sites
18 countries
Phase:
NCT07506109
Phase 2
Recruiting
49 patients
Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of onl...
China
NCT06978400
Phase 2
Recruiting
64 patients
The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mut...
Russia
NCT02465060
Phase 2
Active
6,452 patients
Medications:
Adavosertib
Afatinib
Binimetinib
Capivasertib
Copanlisib
Crizotinib
Dabrafenib
Dasatinib
Defactinib
Erdafitinib
Fexagratinib
Ipatasertib
Larotrectinib
Nivolumab
Osimertinib
Palbociclib
Pertuzumab
Relatlimab
Sapanisertib
Taselisib
Trametinib
Trastuzumab
Ulixertinib
Vismodegib
This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, l...
United States, Guam, Puerto Rico
NCT07440290
Phase 2
Not yet recruiting
30 patients
Medications:
Dabrafenib
Trametinib
This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a ...
United Kingdom
NCT04294160
Phase 1
Completed
122 patients
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
United States, Australia, Belgium, Canada, Germany, Israel, Netherlands, Singapore, Spain, United Ki
NCT03668431
Phase 2
Completed
Medications:
Dabrafenib
Trametinib
This research study is studying a combination of drugs as a possible treatment for metastatic colorectal cancer characterized by BRAF V600E mutation.
The names of the study drugs involved in this study are:
* Dabrafenib
* Trametinib
* PDR001
United States
NCT01750918
Phase 1
Completed
166 patients
This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF i...
United States, Belgium, France, Italy, Japan, Netherlands, Spain, United Kingdom