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
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Differentiated Thyroid Cancer (DTC)
In brief
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.
Key facts
- Study ID
- NCT04940052
- Run by
- Novartis Pharmaceuticals
- People needed
- 153
- Starts
- 2021-11-15
- Expected to finish
- 2027-05-25
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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