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OpenTrials
Completed

NCT Number: NCT00503412

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

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.

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Key information

Conditions

Advanced Solid Metastatic Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Sutton, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2171

Drug

oral 14C

Other names: cediranib, RECENTIN™

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Jul 18, 2007
Registry last updated
Jan 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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