Trials / Terminated
TerminatedNCT04784520
A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer
A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HA121-28 tablets | HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days) |
Timeline
- Start date
- 2021-06-22
- Primary completion
- 2022-12-28
- Completion
- 2022-12-28
- First posted
- 2021-03-05
- Last updated
- 2023-02-06
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04784520. Inclusion in this directory is not an endorsement.