Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours

Phase 1CompletedNCT00621725

AstraZeneca36 enrolled

Overview

To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer Hepatic Impairment

Interventions

AZD2171DRUG

Oral dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent * Advanced solid tumour (not prostate cancer) for which no standard therapy exists * WHO performance status 0-2 * Bilirubin levels within the target range Exclusion Criteria: * Unstable brain/meningeal metastases * Inadequate bone marrow reserve * Biochemistry/haematology results outside of required ranges * History of significant GI impairment

Locations (3)

Research Site

København Ø, Denmark

Research Site

Nijmegen, Netherlands

Research Site

Rotterdam, Netherlands

Outcomes

Primary Outcomes

To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).

Time frame: Single dose PK assessed on Day 1 of dosing

Secondary Outcomes

Safety/tolerability of Cediranib (single and multiple dose PK)

Single and multiple dose PK assessed on Day 1 of the single dosing period and Day 21 of the multiple dosing period, respectively (minimum 7 day washout following single dosing)

Time frame: assessed from randomisation to data cut-off (15th July 2010)

Data from ClinicalTrials.gov

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