Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05770882
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-02-07
Brief Title:
Chidamide Regorafenib in Hepatocellular Carcinoma HCC
Sponsor:
Great Novel Therapeutics Biotech Medicals Corporation
Organization:
Great Novel Therapeutics Biotech Medicals Corporation
Study Overview
Official Title:
A Phase IbII Two-part Non-randomized Open-label Study to Evaluate the Safety Tolerability Efficacy and Pharmacokinetics of Chidamide in Combination With Regorafenib in Patients With Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-03
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:
This open-label phase IbII multicenter study evaluated the safety tolerability efficacy and PK of chidamide in combination with regorafenib in patients with HCC Chidamide a histone deacetylase inhibitor functions as a tumor inhibitor Regorafenib a receptor tyrosine kinase inhibitor was approved as second-line systemic treatment for HCC patients
Detailed Description:
This is an open-label multicenter phase IbII study which includes a Part I phase Ib and a Cohort Expansion part Part II phase II Part I of the study is designed to assess the safety tolerability PK profiles efficacy and PD biomarkers of the study medications in patients with HCC Part II of the study is designed to assess the efficacy safety and PD biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None