NCT00750425CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
Study Overview
Brief Summary
Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone
Intervention: cediranib (RECENTIN TM, AZD2171) (Drug)
Outcomes
Primary Outcomes
To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
Time Frame: PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Secondary Outcomes
- Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.(Until study drug is discountinued)
Investigators
Study Sites (1)
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