Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03568422
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2018-06-13
Brief Title:
CFI-402257 in Combination With Paclitaxel in Patients With AdvancedMetastatic HER2-Negative Breast Cancer
Sponsor:
Canadian Cancer Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination With Weekly Paclitaxel in Patients With AdvancedMetastatic HER2-Negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The standard or usual treatment for this disease is to undergo chemotherapy to slow the spread of disease and relieve some symptoms of cancer One of the standard types of chemotherapy is a drug called paclitaxel Taxol given in a low dose every week for three out of four weeks
CFI-402257 is a new type of drug for breast cancer Laboratory tests show that it may help slow the growth of breast cancer This drug has been shown to shrink tumours in animals CFI-402257 has been studied in a few people and appears well tolerated with little side effects CFI-402257 seems promising but it is not clear if it can offer better results when given with paclitaxel compared to paclitaxel alone
CFI-402257 is a new type of drug for breast cancer Laboratory tests show that it may help slow the growth of breast cancer This drug has been shown to shrink tumours in animals CFI-402257 has been studied in a few people and appears well tolerated with little side effects CFI-402257 seems promising but it is not clear if it can offer better results when given with paclitaxel compared to paclitaxel alone
Detailed Description:
Phase I
The purpose of the first phase of the study is to find the highest dose of CFI-402257 that can be tolerated without causing very severe side effects when receiving paclitaxel This is done by starting at a dose lower than the one that is tolerated in patients when given on its own Participants are given CFI-402257 together with paclitaxel and are watched very closely to see what side effects they have and to make sure the side effects are not severe If the side effects are not severe then new participants will be given a higher dose of CFI-402257 Participants joining this study later on will get higher doses of CFI-402257 than participants who join earlier This will continue until a dose is found that causes severe but temporary side effects Doses higher than that will not be given
Phase II
The purpose of the second phase will be to find out the effect that CFI-402257 has on breast cancer using doses found to be safe in the first phase of the study when given with paclitaxel
The purpose of the first phase of the study is to find the highest dose of CFI-402257 that can be tolerated without causing very severe side effects when receiving paclitaxel This is done by starting at a dose lower than the one that is tolerated in patients when given on its own Participants are given CFI-402257 together with paclitaxel and are watched very closely to see what side effects they have and to make sure the side effects are not severe If the side effects are not severe then new participants will be given a higher dose of CFI-402257 Participants joining this study later on will get higher doses of CFI-402257 than participants who join earlier This will continue until a dose is found that causes severe but temporary side effects Doses higher than that will not be given
Phase II
The purpose of the second phase will be to find out the effect that CFI-402257 has on breast cancer using doses found to be safe in the first phase of the study when given with paclitaxel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None