Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03607188
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2018-07-23
Brief Title:
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
Sponsor:
Suzhou Zelgen Biopharmaceuticals CoLtd
Organization:
Suzhou Zelgen Biopharmaceuticals CoLtd
Study Overview
Official Title:
A Phase I Tolerance Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib
Status:
COMPLETED
Status Verified Date:
2024-03
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:
NSCLC
Brief Summary:
To explore the DLT of ZG0418 for Patients with Advanced ALK or ROS1 NSCLC And Previously Treated with Chemotherapy or Crizotinib and to determine the MTD or the R2PD
Detailed Description:
The study is a randomized double-blind phase 1 trial including 2 sequential parts single ascending doseSAD partmultiple ascending doseMAD part SAD and MAD are dose-escalated tolerant study designing The aims of the study as below
1 Evaluating the safety and tolerance of ZG0418 in ALK NSCLC
2 Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK NSCLCJaktinib
3 Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK NSCLC
4 Analysis the metabolites of ZG0418
1 Evaluating the safety and tolerance of ZG0418 in ALK NSCLC
2 Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK NSCLCJaktinib
3 Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK NSCLC
4 Analysis the metabolites of ZG0418
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?:
None
Is an FDA AA801 Violation?:
None