Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer
This study has been completed.
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First received: July 3, 2007
Last updated: January 24, 2011
Last verified: January 2011
A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability In Patients with Advanced Colorectal Cancer and Liver Metastases.
Drug: ZD6474 (Zactima)
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR)
Procedure: Biomarker Draws
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability In Patients With Advanced Colorectal Cancer and Liver Metastases|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Assess by dynamic contrast-enhanced magnetic resonance imaging the effect of once daily dosing with ZD6474 on tumour perfusion and vascular permeability in patients with advanced colorectal cancer and liver metastases.
Secondary Outcome Measures:
- Assessment of appropriate Pharmacokinetic parameters [ Time Frame: Predetermined timepoints after dose administration ]
- Determine the population PK of ZD6474 and assess the relationship between both free and total plasma PK and measures of Pharmacological activity [ Time Frame: Predetermined timepoints after dose administration ]
- Assessment of the effectiveness of ZD6474 as measured by objective response rate and progression free survival based on RECIST.
|Study Start Date:||August 2006|
|Study Completion Date:||October 2007|
Contacts and Locations