Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04211922
Status:
TERMINATED
Last Update Posted:
2024-04-26
First Post:
2019-12-23
Brief Title:
Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Sponsor:
Suzhou Zelgen Biopharmaceuticals CoLtd
Organization:
Suzhou Zelgen Biopharmaceuticals CoLtd
Study Overview
Official Title:
A Phase II Multicenter Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor RD Strategy Adjustment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinibWhile exploring the relationship between biomarkers and drug efficacy and safety
Detailed Description:
The drug being tested in this study is called alkotinib Alkotinib has been demonstrated to benefit people with ALK NSCLC
The study is a non-control study
The study will enroll approximately 104 participants All participants will take alkotinib 300mg throughout the study
This multi-center trial will be conducted in China The overall time to participate in this study is 3 years Participants will make multiple visits to the site and 28 days after last dose of study drug for a follow-up assessment
The study is a non-control study
The study will enroll approximately 104 participants All participants will take alkotinib 300mg throughout the study
This multi-center trial will be conducted in China The overall time to participate in this study is 3 years Participants will make multiple visits to the site and 28 days after last dose of study drug for a follow-up assessment
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