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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00503412
First received: July 16, 2007
Last updated: January 15, 2009
Last verified: January 2009
July 16, 2007
January 15, 2009
November 2005
Not Provided
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 ]
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
Complete list of historical versions of study NCT00503412 on ClinicalTrials.gov Archive Site
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Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Metastatic Tumor
Drug: AZD2171
oral 14C
Other Names:
  • cediranib
  • RECENTIN™
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
May 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00503412
D8480C00019
Yes
Not Provided
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AstraZeneca
Not Provided
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: Stan Kaye, Prod Royal Marsden NHS Foundation Trust
AstraZeneca
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP