CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 31 enrolled
Drug / intervention
HA121-28 tabletsdrug
Likely dose
HA121-28 tablets 600 mgfrom 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/NCT04784520
NCT04784520Phase 2Terminated
Terminated
CompareCT.gov

A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·interventional·Posted Mar 5, 2021·Updated Feb 6, 2023

In Brief

A Phase 2 clinical trial evaluating HA121-28 tablets for Biliary Tract Cancer. Terminated early, enrolled 31 participants across 2 sites.

Signals

Trial was terminated early

Detailed Summary

This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC). A total of approximately 30 subjects with advanced BTC will be enrolled. The subjects will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Tract Cancer
CountriesChina
Collaborators--

Timeline

Phase 2TerminatedFinished
20222023202420252026
First PostedMar 5, 2021
Enrollment StartJun 22, 2021
Primary CompletionDec 28, 2022
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 5.3 years ago

Interventions

HA121-28 tabletsdrug

HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)