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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Cediranib; Ketoconazole

Criteria

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