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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Metastatic Tumor

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

assessed at time intervals post dose

Safety Issue:

No

Principal Investigator

Nick Botwood, BSc, MBBS, MRCP, MFPM

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D8480C00019

NCT ID:

NCT00503412

Start Date:

November 2005

Completion Date:

May 2006

Related Keywords:

  • Advanced Solid Metastatic Tumor
  • phase I
  • AZD2171
  • solid tumor
  • metastatic tumor
  • Neoplasm Metastasis

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