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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00621725
First received: February 13, 2008
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety/tolerability of Cediranib (single and multiple dose PK) [ Time Frame: assessed from randomisation to data cut-off (15th July 2010) ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00621725

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

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:
Advanced cancer
metastatic
hepatic impairment

Additional relevant MeSH terms:
Neoplasms
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014