NCT04076761

Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma

A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA Trial)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, open-label, single arm phase 2 study to assess the efficacy of TRIFLURIDINE/TIPIRACIL, in patients with advanced cholangiocarcinoma as measured by median progression-free survival (PFS). This study will enroll a total of 47 patients over a 12-month period, according to a two stage enrollment design. Nine patients will be enrolled during the first stage and the trial will be terminated if 4 or more out of the 9 have disease progression. If the trial goes on to the second stage, a total of 47 patients (38 in second stage) will be required. Patients will be seen prior to enrolment (within 28 days of treatment), every 4 weeks while on treatment, at the end of treatment, and 30 days post-treatment. Patients will remain on long-term follow-up and will be seen every 12 weeks (+/- 14 days) until 1 year post-treatment when they will enter into the survival follow-up period and will be contacted every 12 weeks by phone until progression or toxicity.

Conditions

• Cholangiocarcinoma
• Bile Duct Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil	FTD/TPI is an orally administered combination of a thymidine-based nucleic acid analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil hydrochloride. Trifluridine is the active cytotoxic component of FTD/TPI; its triphosphate form is incorporated into DNA, with such incorporation appearing to result in its anti- tumor effects. Tipiracil hydrochloride is a potent inhibitor of thymidine phosphorylase and, when combined with trifluridine to form FTD/TPI, prevents the rapid degradation of the trifluridine, allowing for the maintenance of adequate plasma levels of the active drug.

Timeline

• Start date: 2019-12-11
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2019-09-03
• Last updated: 2022-12-01

Locations

1 site across 1 country: Canada