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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421004
• Other study ID #: CTKI258A2128
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Excluding Breast Cancer
• Neoplasms

Intervention

Drug:
• TKI258

Locations

Country	Name	City	State
United States	Montefiore Medical Center Montefiore Medical Center (SC)	Bronx	New York
United States	Rush University Medical Center Rush 3	Chicago	Illinois
United States	Sammons Cancer Center - Texas Oncology SC-2	Dallas	Texas
United States	City of Hope National Medical Center SC-2	Duarte	California
United States	Florida Cancer Specialists Sarasota Office	Fort Myers	Florida
United States	University of California at Los Angeles UCLA LeConte Location	Los Angeles	California
United States	University of Wisconsin Univ Wisc	Madison	Wisconsin
United States	Sarah Cannon Research Institute Sarah Cannon Research (SC)	Nashville	Tennessee
United States	University of Oklahoma Health Sciences Center OUHSC - SC	Oklahoma City	Oklahoma
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine SC	Saint Louis	Missouri
United States	University of Utah / Huntsman Cancer Institute Huntsman	Salt Lake City	Utah
United States	Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)	San Antonio	Texas
United States	University of California San Francisco UCSF (SC)	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		9 days
Secondary	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		up to 30 days after the last dose of study drug
Secondary	Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer		Every 8 weeks until progression of disease

External Links

•   Results for CTKI258A2128 can be found on the Novartis Clinical Trial Results Website