Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436885
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-22
Brief Title:
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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 is a single-arm open multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer
Detailed Description:
Iruplinalkib Tablets should be administered orally at a roughly fixed time each day Once daily on an empty stomach or with food 60mg per dose for days 1 to 7 180 mg per dose from day 8 if tolerated Swallow the tablet whole do not crush divide or chew the tablet
The primary end point was objective response rate
The primary end point was objective response rate
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