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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: February 13, 2008
Last updated: July 14, 2014
Last verified: July 2014
To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.

Condition Intervention Phase
Advanced Cancer Hepatic Impairment Drug: AZD2171 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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)

Enrollment: 36
Study Start Date: January 2008
Study Completion Date: January 2014
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD2171
Oral dose
Other Name: Cediranib


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: February 13, 2008
Last Updated: July 14, 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 processed this record on September 21, 2017