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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors; Excluding Breast Cancer

Treatments: Drug: TKI258

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421004

CTKI258A2128

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

500 mg FMI capsule + 250 mg FMI tablet

Experimental group

Description:

BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet

Treatment:

Drug: TKI258

500 mg TKI258 FMI capsule +250 mg FMI tablet

Experimental group

Description:

BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule

Treatment:

Drug: TKI258