Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 7:52 PM
Study NCT ID:
NCT01668550
Status:
TERMINATED
Last Update Posted:
2018-02-05
First Post:
2012-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of AZD0424 Alone and in Combination in Advanced Solid Tumours
Sponsor:
Cancer Research UK
Organization:
Study Overview
Official Title:
A Cancer Research UK Phase I Study to Determine the Maximum Tolerated Dose of the Oral Src/Abl Inhibitor AZD0424, and to Identify Tolerable and Effective AZD0424 Combination Regimens for the Treatment of Advanced Solid Tumours
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Single agent phase completed, insufficient supportive preclinical data to proceed with combination phase
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZD0424
Brief Summary:
The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the treatment of advanced solid tumours
Detailed Description:
AZD0424 is a potent orally available, potent (IC50 approximately 4 nM) inhibitor of Src and ABL1 kinases with additional activity against Src family kinase (SFK) members including Yes and Lck. AZD0424 was selective for SFKs and ABL1 kinase over C-terminal Src kinase (a negative regulator of Src) and a range of other kinase targets. The anti-cancer activity of AZD0424 is thought to be mediated primarily by anti-migratory and anti-invasive signalling and, as such, it is expected that in the late stage cancer setting strong signals of efficacy with this compound used as a single agent are unlikely, requiring it to be administered in combination with other anti-cancer agents.
In summary the study will be performed in four main stages:
* AZD0424 monotherapy, dose escalation: Phase Ia single agent (AZD0424) dose escalation study to determine the MTD.
* AZD0424 monotherapy, dose expansion: Phase Ib single agent dose expansion at MTD (up to six additional patients may be recruited in order to provide paired tumour biopsies for PD analysis).
* Combination arm dose escalation: Provided that it is deemed appropriate (after review of available clinical data from the monotherapy part of the trial, and available preclinical and published data on the combination), a Phase Ia dose escalation arm of AZD0424 in combination with the selected agent will proceed to determine the MTD for the combination and a recommended Phase II dose.
* Combination arm dose expansion: Phase Ib combination arm using the recommended Phase II dose for both AZD0424 and the combination agent.
In summary the study will be performed in four main stages:
* AZD0424 monotherapy, dose escalation: Phase Ia single agent (AZD0424) dose escalation study to determine the MTD.
* AZD0424 monotherapy, dose expansion: Phase Ib single agent dose expansion at MTD (up to six additional patients may be recruited in order to provide paired tumour biopsies for PD analysis).
* Combination arm dose escalation: Provided that it is deemed appropriate (after review of available clinical data from the monotherapy part of the trial, and available preclinical and published data on the combination), a Phase Ia dose escalation arm of AZD0424 in combination with the selected agent will proceed to determine the MTD for the combination and a recommended Phase II dose.
* Combination arm dose expansion: Phase Ib combination arm using the recommended Phase II dose for both AZD0424 and the combination agent.
Study Oversight
Has Oversight DMC:
False
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?: