NCT00503412

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
Last Updated

January 19, 2009

Status Verified

January 1, 2009

First QC Date

July 16, 2007

Last Update Submit

January 15, 2009

Conditions

Advanced Solid Metastatic Tumor

Keywords

phase IAZD2171solid tumormetastatic tumor

Outcome Measures

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

    assessed at time intervals post dose

Interventions

AZD2171DRUG

oral 14C

Also known as: cediranib, RECENTIN™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed metastatic tumor which is refractory to standard therapies
  • life expectancy is 12 weeks or longer
  • WHO performance status is 0-12

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nick Botwood, BSc, MBBS, MRCP, MFPM

    AstraZeneca

    STUDY DIRECTOR

  • Stan Kaye, Prod

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

November 1, 2005

Study Completion

May 1, 2006

Last Updated

January 19, 2009

Record last verified: 2009-01

Locations

GB(1)