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

AstraZeneca6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Metastatic Tumor

Interventions

AZD2171DRUG

oral 14C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Sutton, United Kingdom

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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