DeepMed Research

Dabrafenib

Generic Name: Dabrafenib

Brand Names: Tafinlar, Finlee

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₀F_₃N_₅O_₂S_₂

CAS Number: 1195765-45-7

Unique Ingredient Identifier: QGP4HA4G1B

Background: Dabrafenib mesylate (Tafinlar) is a reversible ATP-competitive kinase inhibitor and targets the MAPK pathway. It was approved on May 29, 2013, for the treatment of melanoma with V600E or V6000K mutation. It was also used for metastatic non-small cell lung cancer with the same mutation.

In May 2018, Tafinlar (dabrafenib), in combination with Mekinist (Trametinib), was approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.

Indication: As monotherapy, dabrafenib is indicated to treat unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

In combination with trametinib, dabrafenib is indicated to treat for:

Dabrafenib has limitations of use: it is neither indicated for treating patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition nor wild-type BRAF solid tumours.

Associated Conditions: Locally Advanced Anaplastic Thyroid Cancer, Low-Grade Glioma, Melanoma, Metastatic Anaplastic Thyroid Cancer, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Solid Tumours, Unresectable Melanoma, Unresectable Solid Tumor

Clinical Trials

INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.

Phase 1

Terminated

Conditions: Melanoma

Interventions: Drug: Trametinib
Drug: Dabrafenib
Drug: INCB039110

First Posted Date: 2017-09-05

Last Posted Date: 2023-09-22

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 1

Registration Number: NCT03272464

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer

Phase 2

Conditions: Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation

Interventions: Drug: Trametinib
Drug: Dabrafenib
Radiation: 131I
Drug: rhTSH

First Posted Date: 2017-08-10

Last Posted Date: 2021-09-28

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 40

Registration Number: NCT03244956

Locations: 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France

Efficacy and Safety of Precision Therapy in Refractory Tumor

Phase 2

Conditions: Rare Tumor
Refractory Tumor

Interventions: Drug: Gefitinib
Drug: Erlotinib
Drug: Afatinib
Drug: Trastuzumab
Drug: Oxazolidine
Drug: Olaparib
Drug: Everolimus
Drug: Cabozantinib
Drug: Vemurafenib
Drug: Dabrafenib
Drug: Palbociclib
Drug: PD-1/L1 inhibitor plus anti-angiogenic agent

First Posted Date: 2017-08-03

Last Posted Date: 2022-03-04

Lead Sponsor: Baodong Qin

Target Recruit Count: 300

Registration Number: NCT03239015

Locations: 🇨🇳
Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

Phase 2

Active, not recruiting

Conditions: Metastatic Melanoma

Interventions: Drug: Pembrolizumab
Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2017-05-11

Last Posted Date: 2024-03-21

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 16

Registration Number: NCT03149029

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts general Hospital, Boston, Massachusetts, United States

A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma

Phase 1

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2017-03-27

Last Posted Date: 2024-04-16

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 30

Registration Number: NCT03091257

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States

Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma

Phase 1

Conditions: BRAF Gene Mutation
Melanoma

Interventions: Drug: Talimogene Laherparepvec 1 Million Pfu/Ml Inj,Susp,1Ml,Vil
Drug: Talimogene Laherparep 100 Mil Pfu/Ml 1Ml
Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2017-03-23

Last Posted Date: 2020-10-12

Lead Sponsor: West Cancer Center

Target Recruit Count: 4

Registration Number: NCT03088176

Locations: 🇺🇸
West Cancer Center, Germantown, Tennessee, United States

Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma

Phase 1

Completed

Conditions: Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib
Drug: Phenformin

First Posted Date: 2017-01-20

Last Posted Date: 2025-01-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 18

Registration Number: NCT03026517

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Phase 2

Terminated

Conditions: Melanoma
Brain Metastases

Interventions: Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2016-11-28

Last Posted Date: 2021-08-20

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 6

Registration Number: NCT02974803

Locations: 🇨🇦
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
🇨🇦
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
🇨🇦
Odette Cancer Centre, Toronto, Ontario, Canada

and more 3 locations

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Phase 3

Terminated

Conditions: Melanoma

Interventions: Biological: Spartalizumab
Other: Placebo
Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2016-11-18

Last Posted Date: 2025-04-29

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 568

Registration Number: NCT02967692

Locations: 🇺🇸
California Cancer Associates for Research and Excellence, Encinitas, California, United States
🇺🇸
UC Irvine Medical Center, Orange, California, United States
🇺🇸
California Pacific Medical Center, San Francisco, California, United States

and more 15 locations

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date: 2016-10-05

Last Posted Date: 2024-01-24

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 1550

Registration Number: NCT02925234

Locations: 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱
Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations

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