Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01791985
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2013-02-13
Brief Title:
AZD4547 Anastrozole or Letrozole NSAIs in ER Breast Cancer Patients Who Have Progressed on NSAIs RADICAL
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A Single Arm Phase IIa Study With Combination SRI to Assess the Safety Efficacy of AZD4547 in Combination With Either Anastrozole or Letrozole in ER Breast Cancer Patients Who Have Progressed on Treatment With Anastrozole or Letrozole
Status:
COMPLETED
Status Verified Date:
2022-04
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:
RADICAL
Brief Summary:
This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer AZD4547 is a drug which specifically blocks proteins called fibroblast growth factor receptors FGFR1 that are involved in the processes that help cancer cells to grow These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug
The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547 Stage 1 only
The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547 Stage 1 only
Detailed Description:
The study will be carried out in two stages Stage 1 is to find a suitable dose of AZD4547 which can be used together with a class of drugs called nonsteroidal aromatase inhibitors eg anastrozole or letrozole ie a dose which does not cause too many unacceptable side effects
Patients with hormone sensitive oestrogen receptor positive breast cancer whose current treatment with anastrozole or letrozole has recently stopped working properly will be eligible for this stage
Stage 2 will then assess the efficacy of AZD4547 based on the change in tumour size at 12 weeks or progression if prior to week 12 when used in combination with either anastrozole or letrozole in patients with hormone sensitive oestrogen receptor positive breast cancer who have progressed on treatment with either anastrozole or letrozole in any setting
In both stages the study will look at how well the new treatment is tolerated
Each patient is only allowed to take part in either stage 1 or 2
The study will be run in 9 Hospitals across England and Scotland
Patients with hormone sensitive oestrogen receptor positive breast cancer whose current treatment with anastrozole or letrozole has recently stopped working properly will be eligible for this stage
Stage 2 will then assess the efficacy of AZD4547 based on the change in tumour size at 12 weeks or progression if prior to week 12 when used in combination with either anastrozole or letrozole in patients with hormone sensitive oestrogen receptor positive breast cancer who have progressed on treatment with either anastrozole or letrozole in any setting
In both stages the study will look at how well the new treatment is tolerated
Each patient is only allowed to take part in either stage 1 or 2
The study will be run in 9 Hospitals across England and Scotland
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 |
|---|---|---|---|
| 2011-000454-32 | EUDRACT_NUMBER | None | None |