Viewing Study NCT04084717



Ignite Creation Date: 2024-05-06 @ 1:38 PM
Last Modification Date: 2024-10-26 @ 1:17 PM
Study NCT ID: NCT04084717
Status: RECRUITING
Last Update Posted: 2023-06-18
First Post: 2019-09-08

Brief Title: Study of Crizotinib for ROS1 and MET Activated Lung Cancer
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer CROME
Status: RECRUITING
Status Verified Date: 2024-07
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 phase 2 study of a drug called crizotinib in people with metastatic the cancer has spread to other parts of the body non-small cell lung cancer with a mutation change in genes called ROS1 or MET The purpose of this study is to look at how effective crizotinib is at treating ROS1 or MET mutated non-small cell lung cancer

Crizotinib also called XALKORI is a chemotherapy drug that is currently approved for the treatment of ALK- or ROS1- positive advanced non-small cell lung cancer
Detailed Description: The study consists of a screening period study drug period end of study drug visit and follow-up period

During the screening period participants will be asked to have tests and procedures done to make sure that they are eligible to continue in the study Screening may take several visits Participants found to be eligible to continue in the study will then enter the study drug period where they will take the study drug and have tests and procedures done about once a week for safety and for research purposes

Participants who stop the study drug completely for any reason will be asked to return to the clinic for an end of study drug visit about 28 days after their last dose of study drug to have tests and procedures done for safety and for research purposes Participants that are experiencing any side effects during this time will be closely followed by their study Doctor until the side effects have resolved or stabilized

Participants who discontinue study drug for any reason other than disease progression will be asked to have radiological imaging every 8 weeks to follow up on the status of their disease until disease progression or the start a new treatment for their cancer

After their final visit the study nurse will call participants approximately every 3 months to check on the status of their health

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
Secondary IDs
Secondary ID Type Domain Link
CROME WI235747 OTHER Princess Margaret Cancer Centre None