A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
Trial Information
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
Inclusion Criteria:
- Written informed consent
- Histological or cytological confirmation of advanced solid tumour (with the exception
of prostate cancer), which is refractory to standard therapies or for which no
standard therapy exists.
- Estimated life expectancy of at least 8 weeks
- WHO performance status (PS) 0-2.
Exclusion Criteria:
- Unstable brain/meningeal metastases
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
- Inadequate bone marrow reserve
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
Outcome Time Frame:
PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Safety Issue:
No
Principal Investigator
Jane Roberston
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca Aderley Park
Authority:
Denmark: Danish Medicines Agency
Study ID:
D8480C00020
NCT ID:
NCT00750425
Start Date:
August 2008
Completion Date:
January 2011
Related Keywords:
- Advanced Solid Tumors
- advanced cancer,
- metastatic
- ketoconazole
- pharmacokinetics
- Phase I
- Neoplasms
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