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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503412

Enrollment

Registered

2007-07-18

Start date

2005-11-30

Completion date

2006-05-31

Last updated

2009-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Metastatic Tumor

Keywords

phase I, AZD2171, solid tumor, metastatic tumor

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.

Interventions

DRUGAZD2171

oral 14C

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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	assessed at time intervals post dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026