Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors

Status:	Completed
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	9/23/2012
Start Date:	December 2011
End Date:	January 2013
Contact:	Novartis Pharmaceuticals
Phone:	+1(800)340-6843

A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors

This is a multi-center, open-label, two way crossover study designed to test the
bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients
with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate
that those 2 formulations are considered to be the same for all intents and purposes by
making sure they are acting on the body with the same strength and are absorbed in similar
amounts by the body. During the bioequivalence phase, patients will take orally at a daily
dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days
on/2days off dosing schedule, after which time, patients will switch to the alternate
formulation for one additional week. After the bioequivalence phase, all patients may
continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until
disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or
discontinuation from the study treatment for any other reason.

Inclusion Criteria:

1. Patients with a histopathologically or cytopathologically confirmed diagnosis of an
advanced solid tumor, excluding breast cancer, who have progressed despite standard
therapy, or for which no standard therapy exists

2. ECOG performance status (PS) 0, 1 or 2

3. Patients must meet protocol-specified laboratory values

Exclusion Criteria:

1. Patients with brain metastases

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

3. Patients who have not recovered from previous anti-cancer therapies

4. Patients who are expected to receive any prohibited medications during the
bioequivalence phase of the study

5. Female patients who are pregnant, breast feeding

6. Fertile male or women of child-bearing potential not willing to use two highly
effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply

We found this trial at

sites

Sarah Cannon Research Institute Sarah Cannon Research (SC)

Nashville, Tennessee 37203

from

Nashville, TN