Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562543
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced Previously Treated Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High blood pressure hypertension is a known side effect of the treatment with fruquintinib Current research does not provide a clear answer whether minority groups such as BlackAfrican American andor HispanicLatino with refractory metastatic colorectal cancer mCRC have a bigger risk of higher blood pressure after treatment with fruquintinib The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants
Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens they do no longer tolerate the treatment or stop the treatment for other reasons After the last treatment participants will be checked upon every 3 months until study completion
Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens they do no longer tolerate the treatment or stop the treatment for other reasons After the last treatment participants will be checked upon every 3 months until study completion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None