Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT03836768
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2019-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma
Sponsor:
Zhejiang DTRM Biopharma
Organization:
Study Overview
Official Title:
A Phase Ib Study of BTK Inhibitor DTRMWXHS-12 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: