Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843188
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-03-29
Brief Title:
Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of 5-FU Irinotecan Bevacizumab and Hydroxychloroquine in Drug-Tolerant Persister DTP-Selected Patients With Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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 two arm 2-center Phase II study of 5-FU irinotecan bevacizumab FOLFIRI-beva and hydroxychloroquine HCQ in patients with previously untreated metastatic colorectal cancer mCRC
Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ
Patients will continue to receive treatments until evidence of disease progression intolerable side effects withdrawal of consent or death
Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ
Patients will continue to receive treatments until evidence of disease progression intolerable side effects withdrawal of consent or death
Detailed Description:
None
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 |
|---|---|---|---|
| 22-5689 | OTHER | University Health Network | None |