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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503412
First Posted: July 18, 2007
Last Update Posted: January 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Advanced Solid Metastatic Tumor Drug: AZD2171 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by AstraZeneca:

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 [ Time Frame: assessed at time intervals post dose ]

Enrollment: 6
Study Start Date: November 2005
Study Completion Date: May 2006
Intervention Details:
    Drug: AZD2171
    oral 14C
    Other Names:
    • cediranib
    • RECENTIN™
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503412


Locations
United Kingdom
Research Site
Sutton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: Stan Kaye, Prod Royal Marsden NHS Foundation Trust
  More Information

ClinicalTrials.gov Identifier: NCT00503412     History of Changes
Other Study ID Numbers: D8480C00019
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: January 19, 2009
Last Verified: January 2009

Keywords provided by AstraZeneca:
phase I
AZD2171
solid tumor
metastatic tumor

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Cediranib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action