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Активно (без набиране) Фаза 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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Differentiated Thyroid Cancer

Спонсор: Exelixis

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 24
Argentina (1)
Exelixis Clinical Site #96
Pergamino , Buenos Aires
Австралия (1)
Exelixis Clinical Site #17
St Leonards , New South Wales
Белгия (1)
Exelixis Clinical Site #90
Anderlecht
Бразилия (1)
Exelixis Clinical Site #35
Cascavel , Paraná
Канада (1)
Exelixis Clinical Site #20
Calgary , Alberta
Хърватия (1)
Exelixis Clinical Site #145
Osijek
Чехия (1)
Exelixis Clinical Site #105
Brno
Франция (1)
Exelixis Clinical Site #32
Dijon , Bourgogne-Franche-Comté
Германия (1)
Exelixis Clinical Site #121
Tübingen , Baden-Wurttemberg
Hong Kong (1)
Exelixis Clinical Site #28
Hong Kong
Унгария (1)
Exelixis Clinical Site #46
Budapest
Израел (1)
Exelixis Clinical Site #43
Haifa
Италия (1)
Exelixis Clinical Site #109
Viagrande , Catania
Mexico (1)
Exelixis Clinical Site #158
Tuxtla Gutiérrez , Chiapas
Нидерландия (1)
Exelixis Clinical Site #128
Amsterdam , North Holland
Полша (1)
Exelixis Clinical Site #59
Poznan , Greater Poland Voivodeship
Румъния (1)
Exelixis Clinical Site #149
Cluj-Napoca , Cluj
Russia (1)
Exelixis Clinical Site #48
Obninsk , Kaluzhiskiy Region
Южна Корея (1)
Exelixis Clinical Site #70
Busan
Испания (1)
Exelixis Clinical Site #14
Barcelona
Taiwan (1)
Exelixis Clinical Site #136
Tainan
Тайланд (1)
Exelixis Clinical Site #126
Bangkok Noi , Bangkok
Великобритания (1)
Exelixis Clinical Site #88
Birmingham , England
САЩ (1)
Exelixis Clinical Site #2
Newport Beach , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Здрави доброволци
Не
Начална дата
05.10.2018
Крайна дата
31.07.2026
Регистрационен номер
NCT03690388
Източник
anzctr
Запитване за медицински туризъм

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