Study of 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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

January 22, 2025

Study Completion Date

June 4, 2027

Conditions
Differentiated Thyroid Cancer
Interventions
DRUG

Dabrafenib

Dabrafenib will be administered orally twice daily

DRUG

Trametinib

Trametinib will be administered orally once daily

DRUG

Trametinib placebo

Trametinib will be administered orally once daily

DRUG

Dabrafenib placebo

Dabrafenib placebo will be administered orally twice daily

Trial Locations (41)

10002

Novartis Investigative Site, Taipei

10450

Novartis Investigative Site, George Town

22030

Novartis Investigative Site, Edirne

34098

Novartis Investigative Site, Istanbul

59100

Novartis Investigative Site, Kuala Lumpur

60611

Northwestern University Med School, Chicago

70403

Novartis Investigative Site, Tainan City

93586

Novartis Investigative Site, Kuching

100000

Novartis Investigative Site, Hanoi

100036

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

110029

Novartis Investigative Site, New Delhi

125005

Novartis Investigative Site, Hisar

130033

Novartis Investigative Site, Changchun

200233

Novartis Investigative Site, Shanghai

210006

Novartis Investigative Site, Nanjing

210009

Novartis Investigative Site, Nanjing

221003

Novartis Investigative Site, Xuzhou

300052

Novartis Investigative Site, Tianjin

300121

Novartis Investigative Site, Tianjin

300480

Novartis Investigative Site, Tianjin

350014

Novartis Investigative Site, Fuzhou

410013

Novartis Investigative Site, Changsha

430022

Novartis Investigative Site, Wuhan

450008

Novartis Investigative Site, Zhengzhou

510060

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

02114

Massachusetts General Hospital, Boston

C1417DTB

Novartis Investigative Site, CABA

20231-050

Novartis Investigative Site, Rio de Janiero

89015-200

Novartis Investigative Site, Blumenau

01246-000

Novartis Investigative Site, São Paulo

T6G 1Z2

Novartis Investigative Site, Edmonton

N6A 5W9

Novartis Investigative Site, London

600 020

Novartis Investigative Site, Chennai

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

06500

Novartis Investigative Site, Ankara

01250

Novartis Investigative Site, Adana

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY