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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621725
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Hepatic Impairment Drug: AZD2171 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: 1 Drug: AZD2171
Oral dose
Other Name: Cediranib

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621725

Research Site
København Ø, Denmark
Research Site
Nijmegen, Netherlands
Research Site
Rotterdam, Netherlands
Sponsors and Collaborators
Principal Investigator: CML van Herpen, MD Radboud University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00621725     History of Changes
Other Study ID Numbers: D8480C00032
EUDRACT number 2007-005145-38
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by AstraZeneca:
Advanced cancer
hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action