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NCT00621725 Clinical Trial

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

Advanced Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621725
Other study ID # D8480C00032
Secondary ID EUDRACT number 2
Status Completed
Phase Phase 1
First received February 13, 2008
Last updated July 14, 2014
Start date January 2008
Est. completion date January 2014

Study information
Verified date July 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 2014
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2171
Oral dose

Locations
Country Name City State
Denmark Research Site København Ø
Netherlands Research Site Nijmegen
Netherlands Research Site Rotterdam

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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) assessed from randomisation to data cut-off (15th July 2010) No
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