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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Metastatic Tumor

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503412

D8480C00019

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)