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

Novartis Pharmaceuticals166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

166

Conditions

Advanced Solid Tumors Excluding Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

City of Hope National Medical Center SC-2

Duarte, California, United States

University of California at Los Angeles UCLA LeConte Location

Los Angeles, California, United States

University of California San Francisco UCSF (SC)

San Francisco, California, United States

Florida Cancer Specialists Sarasota Office

Fort Myers, Florida, United States

Rush University Medical Center Rush 3

Chicago, Illinois, United States

Washington University School of Medicine SC

St Louis, Missouri, United States

Montefiore Medical Center Montefiore Medical Center (SC)

The Bronx, New York, United States

University of Oklahoma Health Sciences Center OUHSC - SC

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute Sarah Cannon Research (SC)

Nashville, Tennessee, United States

...and 4 more locations

Outcomes

Primary Outcomes

Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax

Time frame: 9 days

Secondary Outcomes

Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer

Time frame: up to 30 days after the last dose of study drug

Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer

Time frame: Every 8 weeks until progression of disease