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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00503412

Collaborator

(none)

Enrollment

Location

5.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Metastatic Tumor	Drug: AZD2171	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2005

Actual Study Completion Date :

May 1, 2006

Outcome Measures

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 [assessed at time intervals post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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