Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors

Phase 1

Completed

• Conditions: Advanced Solid Metastatic Tumor

• Registration Number: NCT00503412
• Lead Sponsor: AstraZeneca

Brief Summary

Open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and its metabolites.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Study Completion: 2006-05
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-18
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-15
• Last Update Posted: 2009-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• histologically confirmed metastatic tumor which is refractory to standard therapies
• life expectancy is 12 weeks or longer
• WHO performance status is 0-12

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Exclusion Criteria

• radiotherapy and chemotherapy within 4 weeks before the start of the study treatment
• patients with a history of poorly controlled hypertension
• history or evidence of any medical condition that might affect gastrointestinal function
• patients that have participated in a radiolabelled study in the last 5 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective is to determine the rates & routes of excretion of 14C radiolabelled AZD2171 in patients by assessment of concentrations of total 14C radioactivity and AZD2171 in plasma & concentrations of total radioactivity in urine&faeces	assessed at time intervals post dose

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom