Spots Global Cancer Trial Database for A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
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Trial Identification
Brief Title: A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
Official Title: A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)
Study ID: NCT03790111
Conditions
Interventions
Study Description
Brief Summary: A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin \[cis\] plus gemcitabine \[gem\])
Detailed Description: A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis plus gem) is planned.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
TerSera Investigational Site, Gilbert, Arizona, United States
TerSera Investigational Site, Fullerton, California, United States
TerSera Investigational Site, Gainesville, Florida, United States
TerSera Investigational Site, Tampa, Florida, United States
TerSera Investigational Site, Chicago, Illinois, United States
TerSera Investigational Site, Westwood, Kansas, United States
TerSera Investigational Site, Lexington, Kentucky, United States
TerSera Investigational Site, Boston, Massachusetts, United States
TerSera Investigational Site, Grand Rapids, Michigan, United States
TerSera Investigational Site, Buffalo, New York, United States
TerSera Investigational Site, Lake Success, New York, United States
TerSera Investigational Site, Charlotte, North Carolina, United States
TerSera Investigational Site, Oklahoma City, Oklahoma, United States
TerSera Investigational Site, San Antonio, Texas, United States
Contact Details
Name: Renuka Iyer, M.D.
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR
Name: Richard Kim, M.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: STUDY_CHAIR
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