Advanced Solid Tumors
Conditions
Keywords
advanced cancer,, metastatic, ketoconazole, pharmacokinetics, Phase I
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.
Interventions
20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days)
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole. | PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, Denmark
Outcome results
None listed