Back to resultsPhase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
Primary Purpose
Advanced Solid Metastatic Tumor
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD2171
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Metastatic Tumor focused on measuring phase I, AZD2171, solid tumor, metastatic tumor
Eligibility Criteria
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
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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503412
Brief Title
Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
Official Title
A Phase 1, Open Label, Non-Randomised, Single Centre Pharmacokinetic and Mass Balance Study of Orally Administered 14-C-AZD2171 in Patients With Solid Metastatic Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Metastatic Tumor
Keywords
phase I, AZD2171, solid tumor, metastatic tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD2171
Other Intervention Name(s)
cediranib, RECENTIN™
Intervention Description
oral 14C
Primary Outcome Measure Information:
Title
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
Time Frame
assessed at time intervals post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Botwood, BSc, MBBS, MRCP, MFPM
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stan Kaye, Prod
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
We'll reach out to this number within 24 hrs