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

NCT03790111 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-04-19

Study results available
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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 \[gem\])

Conditions

  • Biliary Tract Cancer (BTC)

Interventions

DRUG

telotristat ethyl

XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study

Sponsors & Collaborators

  • TerSera Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Renuka Iyer, M.D. · Roswell Park Cancer Institute

  • Richard Kim, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2022-01-13
Completion
2022-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790111 on ClinicalTrials.gov