Advanced Solid Metastatic Tumor Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | May 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Research Site | Sutton |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |