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

Status:	Completed
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/4/2016
Start Date:	July 2010
End Date:	November 2013

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

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.

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

We found this trial at

sites

Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

Scottsdale, Arizona 85258

from

Scottsdale, AZ