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Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2021-11-15
Completion Date
2027-06-04
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Dabrafenib
Dabrafenib 150 mg capsule administered orally twice a day (BID)
Trametinib
Trametinib 2 mg tablet administered once a day (QD)
Trametinib Placebo
matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD)
Dabrafenib placebo
matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID)
Locations (41)
Northwestern University Med School
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Rio de Janiero, Rio de Janeiro, Brazil
Novartis Investigative Site
Blumenau, Santa Catarina, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Xuzhou, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Hisar, Haryana, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Chennai, India
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Kuala Lumpur, Malaysia
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Tainan, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Edirne, Merkez, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Adana, Yuregir, Turkey (Türkiye)
Novartis Investigative Site
Hanoi, Vietnam