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Active (not recruiting) Phase 3 NCT03690388

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Phase 3 – large-scale trial before approval
Conditions: Differentiated Thyroid Cancer

Sponsor: Exelixis

trial.available_in: БГ
Overview
The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.
Who can participate
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC) 2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC) 4. Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Exclusion Criteria: 1. Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent) 2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization 3. Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization 4. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization. 5. Known brain metastases or cranial epidural disease unless adequately treated
Locations 24
Argentina (1)
Exelixis Clinical Site #96
Pergamino , Buenos Aires
Australia (1)
Exelixis Clinical Site #17
St Leonards , New South Wales
Belgium (1)
Exelixis Clinical Site #90
Anderlecht
Brazil (1)
Exelixis Clinical Site #35
Cascavel , Paraná
Canada (1)
Exelixis Clinical Site #20
Calgary , Alberta
Croatia (1)
Exelixis Clinical Site #145
Osijek
Czech Republic (1)
Exelixis Clinical Site #105
Brno
France (1)
Exelixis Clinical Site #32
Dijon , Bourgogne-Franche-Comté
Germany (1)
Exelixis Clinical Site #121
Tübingen , Baden-Wurttemberg
Hong Kong (1)
Exelixis Clinical Site #28
Hong Kong
Hungary (1)
Exelixis Clinical Site #46
Budapest
Israel (1)
Exelixis Clinical Site #43
Haifa
Italy (1)
Exelixis Clinical Site #109
Viagrande , Catania
Mexico (1)
Exelixis Clinical Site #158
Tuxtla Gutiérrez , Chiapas
Netherlands (1)
Exelixis Clinical Site #128
Amsterdam , North Holland
Poland (1)
Exelixis Clinical Site #59
Poznan , Greater Poland Voivodeship
Romania (1)
Exelixis Clinical Site #149
Cluj-Napoca , Cluj
Russia (1)
Exelixis Clinical Site #48
Obninsk , Kaluzhiskiy Region
South Korea (1)
Exelixis Clinical Site #70
Busan
Spain (1)
Exelixis Clinical Site #14
Barcelona
Taiwan (1)
Exelixis Clinical Site #136
Tainan
Thailand (1)
Exelixis Clinical Site #126
Bangkok Noi , Bangkok
United Kingdom (1)
Exelixis Clinical Site #88
Birmingham , England
United States (1)
Exelixis Clinical Site #2
Newport Beach , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
16 Years
Healthy volunteers
No
Start date
05.10.2018
Completion date
31.07.2026
Registry ID
NCT03690388
Source
anzctr
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