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

January 15, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Advanced Solid Metastatic Tumor

Intervention / Treatment

Drug: AZD2171

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Sutton, United Kingdom
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	assessed at time intervals post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
Principal Investigator: Stan Kaye, Prod, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria