Trials / Active Not Recruiting
Active Not RecruitingNCT04682808
A Study of FCN-338 in Patients With Chronic CLL/SLL
A Phase I Trial to Evaluate the Tolerability、Pharmacokinetics and Preliminary Antitumor Activity of FCN-338 in Patients With CLL/SLL
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- Sponsor
- Fochon Pharmaceuticals, Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being done to evaluate the Tolerability、Pharmacokinetics and Preliminary antitumor activity of oral FCN-338 for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have failed or are intolerant to one or more lines of established therapy or for whom no other treatment options are available.
Detailed description
This is a multicenter, open-label, Phase I dose escalation study of Tolerability、Pharmacokinetics and Preliminary antitumor activity of FCN-338 in ascending cohorts to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FCN-338 | FCN-338 will be given orally in ascending doses starting at 50 mg QD until the maximum tolerated dose or recommended dose is reached. |
Timeline
- Start date
- 2021-05-13
- Primary completion
- 2024-04-28
- Completion
- 2024-12-31
- First posted
- 2020-12-24
- Last updated
- 2024-08-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04682808. Inclusion in this directory is not an endorsement.