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

July 14, 2014 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København Ø, Denmark
        • Research Site
  • Netherlands
      • Nijmegen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AZD2171
Oral dose
Other Names:
  • Cediranib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Single dose PK assessed on Day 1 of dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/tolerability of Cediranib (single and multiple dose PK)
Time Frame: 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)
assessed from randomisation to data cut-off (15th July 2010)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: CML van Herpen, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00032
  • EUDRACT number 2007-005145-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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