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

A Phase I, Open Label Study of the Pharmacokinetics and Safety of Cediranib (RECENTINTM, AZD2171) Following Single and Multiple Oral Doses in Patients With Advanced Solid Tumours With Various Degrees of Hepatic Dysfunction

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00621725
Enrollment
36
Registered
2008-02-22
Start date
2008-01-31
Completion date
2014-01-31
Last updated
2014-07-15

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

Conditions

Advanced Cancer, Hepatic Impairment

Keywords

Advanced cancer, metastatic, hepatic impairment

Brief summary

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

Interventions

DRUGAZD2171

Oral dose

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).Single dose PK assessed on Day 1 of dosing

Secondary

MeasureTime frameDescription
Safety/tolerability of Cediranib (single and multiple dose PK)assessed from randomisation to data cut-off (15th July 2010)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)

Countries

Denmark, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026