A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer — TELE-ABC

Biliary Tract Cancer (BTC) Clinical Trial

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)

Status Terminated

Clinical Trial 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])

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03790111
Study type	Interventional
Source	TerSera Therapeutics LLC
Contact
Status	Terminated
Phase	Phase 2
Start date	March 13, 2019
Completion date	January 13, 2022

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT05036486` - The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Completed	`NCT03314935` - A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04004234` - A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC	Phase 1/Phase 2