NCT01030055

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

A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258, and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neoplasms
• Cancer
• Tumors

Interventions

Type	Name	Description
DRUG	TKI258 (dovitinib)	bioavailability (anhydrate capsules) food (monohydrae capsules)

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-12-11
• Last updated: 2020-12-21

Locations

4 sites across 1 country: United States