Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours
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ClinicalTrials.gov Identifier: NCT00621725 |
Recruitment Status
:
Completed
First Posted
: February 22, 2008
Last Update Posted
: July 15, 2014
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
Tracking Information | ||||
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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 |
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 |
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 |
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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Original Secondary Outcome Measures ICMJE |
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 |
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Condition ICMJE |
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Intervention ICMJE | Drug: AZD2171
Oral dose
Other Name: Cediranib |
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Study Arms | Experimental: 1
Intervention: Drug: AZD2171 |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
36 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |
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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 |