Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours

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 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.

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