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
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
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014