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

Tracking Information
First Submitted Date ICMJE	February 13, 2008
First Posted Date ICMJE	February 22, 2008
Last Update Posted Date	July 15, 2014
Study Start Date ICMJE	January 2008
Actual Primary Completion Date	July 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 8, 2013)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: February 13, 2008)	To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).
Change History	Complete list of historical versions of study NCT00621725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 8, 2013)	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)
Original Secondary Outcome Measures ICMJE; (submitted: February 13, 2008)	Safety/tolerability of Cediranib; single and multiple dose PK
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours
Official Title ICMJE	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
Brief Summary	To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Advanced Cancer; Hepatic Impairment
Intervention ICMJE	Drug: AZD2171; Oral dose; Other Name: Cediranib
Study Arms	Experimental: 1; Intervention: Drug: AZD2171
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 24, 2014)	36
Original Estimated Enrollment ICMJE; (submitted: February 13, 2008)	40
Actual Study Completion Date	January 2014
Actual Primary Completion Date	July 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Denmark, Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00621725
Other Study ID Numbers ICMJE	D8480C00032; EUDRACT number 2007-005145-38
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ICMJE	AstraZeneca
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: CML van Herpen, MD Radboud University
PRS Account	AstraZeneca
Verification Date	July 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP