Safety, Tolerability and PK of BTK Inhibitor DTRMWXHS-12 in Patients With B-Cell Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02891590|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 14, 2020
The Primary Objective is to evaluate the safety and tolerability of multiple dose oral administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.
The Secondary Objective is to evaluate the pharmacokinetics of multiple dose oral administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia B-cell Lymphomas||Drug: DTRMWXHS-12||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ia Study of the Safety, Tolerability and PK of BTK Inhibitor DTRMWXHS-12 in Patients With B-Cell Lymphoma|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||February 2019|
|Actual Study Completion Date :||February 2019|
DTRMWXHS-12 only: oral capsules (50 mg and 150 mg strengths), successive administration, dose escalation from 50mg to 100, 200, 400, 600, 800mg daily until MTD. During successive administration, orally once a day, 28 days as a cycle.
- Number of participants with adverse events [ Time Frame: Starting from date of first dose up to 30 days after last dose ]Confirm the safety and tolerability of multiple dose oral administration of DTRMWXHS-12 capsule
- Plasma concentrations of DTRMWXHS-12 [ Time Frame: Days 1-28 (first treatment cycle) ]DTRMWXHS-12 Pharmacokinetics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891590
|Peking University Cancer Hospital|
|Study Director:||Wei He, Ph.D.||Zhejiang DTRM Biopharma|