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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.
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
History of Changes

February 13, 2008
July 14, 2014
January 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels). [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00621725 on ClinicalTrials.gov Archive Site
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)
Safety/tolerability of Cediranib; single and multiple dose PK [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Cancer
  • Hepatic Impairment
Drug: AZD2171
Oral dose
Other Name: Cediranib
Experimental: 1
Intervention: Drug: AZD2171
van Herpen CM, Lassen U, Desar IM, Brown KH, Marotti M, de Jonge MJ. Pharmacokinetics and tolerability of cediranib, a potent VEGF signalling inhibitor, in cancer patients with hepatic impairment. Anticancer Drugs. 2013 Feb;24(2):204-11. doi: 10.1097/CAD.0b013e32835bd1d2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2014
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Netherlands
 
NCT00621725
D8480C00032, EUDRACT number 2007-005145-38
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: CML van Herpen, MD Radboud University
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP