Phase
Condition
N/ATreatment
Dabrafenib placebo
Trametinib placebo
Trametinib
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent must be obtained prior to performing any specificpre-screening and screening procedure
Male or female >= 18 years of age at the time of informed consent
Histologically or cytologically confirmed diagnosis of advanced/metastaticdifferentiated thyroid cancer
Radio active iodine refractory disease
BRAFV600E mutation positive tumor sample as per Novartis designated centrallaboratory result
Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapy
Eastern Cooperative Oncology Group performance status >= 2
At least one measurable lesion as defined by RECIST 1.1
Exclusion
Exclusion Criteria:
Anaplastic or medullary carcinoma of the Tyroid
Previous treatment with BRAF inhibitor and/or MEK inhibitor
Concomitant RET Fusion Positive Thyroid cancer
Receipt of any type of small molecule kinase inhibitor within 2 weeks beforerandomization
Receipt of any type of cancer antibody or systemic chemotherapy within 4 weeksbefore randomization
Receipt of radiation therapy for bone metastasis within 2 weeks or any otherradiation therapy within 4 weeks before randomization
A history or current evidence/risk of retinal vein occlusion or central serousretinopathy
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1417DTB
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires, C1012AAR
ArgentinaSite Not Available
Novartis Investigative Site
Brasília, Distrito Federal
BrazilSite Not Available
Novartis Investigative Site
Rio De Janiero, RJ 20231-050
BrazilSite Not Available
Novartis Investigative Site
Porto Alegre, RS 91350 200
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 01246-000
BrazilSite Not Available
Novartis Investigative Site
Blumenau, Santa Catarina 89015-200
BrazilSite Not Available
Novartis Investigative Site
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Novartis Investigative Site
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Novartis Investigative Site
London, Ontario N6A 5W9
CanadaSite Not Available
Novartis Investigative Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Novartis Investigative Site
Fuzhou, Fujian 350014
ChinaSite Not Available
Novartis Investigative Site
Zhengzhou, Henan 450008
ChinaSite Not Available
Novartis Investigative Site
Wuhan, Hubei 430022
ChinaSite Not Available
Novartis Investigative Site
Changsha, Hunan 410013
ChinaSite Not Available
Novartis Investigative Site
Nanjing, Jiangsu 210009
ChinaSite Not Available
Novartis Investigative Site
Xuzhou, Jiangsu 221003
ChinaSite Not Available
Novartis Investigative Site
Changchun, Jilin 130033
ChinaSite Not Available
Novartis Investigative Site
XI An, Shanxi 710061
ChinaSite Not Available
Novartis Investigative Site
Xi'an, Shanxi 710032
ChinaSite Not Available
Novartis Investigative Site
Xian, Shanxi 710061
ChinaSite Not Available
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaSite Not Available
Novartis Investigative Site
Kunming City, Yunnan 650000
ChinaSite Not Available
Novartis Investigative Site
Hangzhou, Zhejiang 310014
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100730
ChinaSite Not Available
Novartis Investigative Site
Guangzhou, 510060
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200233
ChinaSite Not Available
Novartis Investigative Site
Tianjin, 300480
ChinaSite Not Available
Novartis Investigative Site
Hisar, Haryana 125005
IndiaSite Not Available
Novartis Investigative Site
Mumbai, Maharashtra 400056
IndiaSite Not Available
Novartis Investigative Site
Vellore, Tamil Nadu 632 004
IndiaSite Not Available
Novartis Investigative Site
Hyderabad, Telangana 500082
IndiaSite Not Available
Novartis Investigative Site
Chennai, 600 020
IndiaSite Not Available
Novartis Investigative Site
New Delhi, 110029
IndiaSite Not Available
Novartis Investigative Site
Seoul, Seocho Gu 06591
Korea, Republic ofSite Not Available
Novartis Investigative Site
Kuching, Sarawak 93586
MalaysiaSite Not Available
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaSite Not Available
Novartis Investigative Site
Pulau Pinang, 10990
MalaysiaSite Not Available
Novartis Investigative Site
Ciudad de Mexico, Mexico CP 14080
MexicoSite Not Available
Novartis Investigative Site
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Novartis Investigative Site
Chihuahua, 31210
MexicoSite Not Available
Novartis Investigative Site
Tainan, 70403
TaiwanSite Not Available
Novartis Investigative Site
Taipei, 10002
TaiwanSite Not Available
Novartis Investigative Site
Istanbul, TUR 34098
TurkeySite Not Available
Novartis Investigative Site
Adana, 01250
TurkeySite Not Available
Novartis Investigative Site
Ankara, 06500
TurkeySite Not Available
Novartis Investigative Site
Edirne, 22030
TurkeySite Not Available
Northwestern University Med School
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern University Medical School
Chicago, Illinois 60611
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital Dept of MGH 2
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital Dept. of MGH (2)
Boston, Massachusetts 02114
United StatesActive - Recruiting
Novartis Investigative Site
Hanoi, 100000
VietnamSite Not Available
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