CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 178 enrolled
Drug / intervention
Onivyde +1 moredrug
Likely dose
Onivyde 70 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03524508
NCT03524508Phase 2Completed
CompareCT.gov

Randomized Phase II Trial of Fluorouracil and Folinic Acid With or Without Liposomal Irinotecan (ONIVYDE) for Patients With Metastatic Biliary Tract Cancer Which Progressed Following Gemcitabine Plus Cisplatin

Changhoon Yoo·interventional·Posted May 14, 2018·Updated Aug 24, 2022

In Brief

A Phase 2 clinical trial evaluating Onivyde and 5-FU/LV for Metastatic Biliary Tract Cancer. Completed, enrolled 178 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of combination of fluorouracil/folinic acid and liposomal irinotecan(Onivyde) compared with fluoruracil/folinic acid in patients with metastatic biliary tract cancer which progressed on 1st line gemcitabine/cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Biliary Tract Cancer
CountriesSouth Korea
CollaboratorsUlsan University Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, Inje University

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 14, 2018
Enrollment StartSep 4, 2018
Primary CompletionSep 30, 2020
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.1 years ago

Interventions

Onivydedrug

The recommended dose and regimen of Onivyde is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks.

5-FU/LVdrug

The recommended dose and regimen of dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks