Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-02 @ 8:25 AM
Study NCT ID:
NCT01795768
Status:
UNKNOWN
Last Update Posted:
2013-03-15
First Post:
2013-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
RECRUITING
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:
FGFR
Brief Summary:
To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy
Detailed Description:
Primary endpoint
\- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
Secondary endpoints
* Objective response rate to AZD4547 in all patients and in each tumour group
* Safety and tolerability of AZD4547 in all patients
* Disease control rate at 8 weeks
* Progression free survival in all patients and in each tumour group
\- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
Secondary endpoints
* Objective response rate to AZD4547 in all patients and in each tumour group
* Safety and tolerability of AZD4547 in all patients
* Disease control rate at 8 weeks
* Progression free survival in all patients and in each tumour group
Study Oversight
Has Oversight DMC:
True
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?: