Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists

• World Health Organization (WHO) performance status ≤ 2

• Patient must meet protocol-specified laboratory values

Exclusion Criteria:

• Patients with brain cancer

• Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study

• Patients who have not recovered from previous anti-cancer therapies

• Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply