Trials / Completed
CompletedNCT03836768
BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma
A Phase Ib Study of BTK Inhibitor DTRMWXHS-12 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Zhejiang DTRM Biopharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study. The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL. The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DTRMWXHS-12 | DTRMWXHS-12 capsules: 150 mg, 300 mg |
Timeline
- Start date
- 2019-01-11
- Primary completion
- 2021-11-17
- Completion
- 2021-11-17
- First posted
- 2019-02-11
- Last updated
- 2023-02-15
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03836768. Inclusion in this directory is not an endorsement.