Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00503412     History of Changes
Other Study ID Numbers: D8480C00019
Study First Received: July 16, 2007
Last Updated: January 15, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on November 24, 2014