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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)
The purpose of this study is to test whether Xermelo® (500 mg given 3 times daily) when given with chemotherapy that is used as a standard treatment for this tumor type (cisplatin [cis]/gemcitabine [gem] chemotherapy [given twice in a 21-day cycle]) will have an effect on the growth of BTC tumor(s).
The primary objective of the study is to assess the safety and efficacy (progression-free survival rate at Month 6) of XERMELO in combination with cisplatin (cis) plus gemcitabine (gem) To assess the effect of study treatment on the following: Overall survival (OS) OS rate at Months 6 and 12 PFS rate at Month 12 and median PFS Disease control rate (DCR); defined as complete response (CR) + partial response (PR) + stable disease (SD) at Months 6 and 12 and End of Study (EOS) Objective response rate (ORR) defined as CR + PR at Months 6 and 12 and EOS Local radiologists assessment of PFS, ORR, and DCR Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) and serum carbohydrate antigen 19-9 (CA 19-9) at Months 6 and 12 and EOS Change from Baseline in body weight at Months 6 and 12 and EOS Change from Baseline in serum albumin at Months 6 and 12 and EOS
Gemzar (gemcitabine); XERMELO (); cisplatin (); gemcitabine ()