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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Excluding Breast Cancer

In brief

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.

Key facts

Study ID

NCT01421004

Run by

Novartis Pharmaceuticals

People needed

166

Starts

2011-12-01

Expected to finish

2014-07-01

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• ECOG performance status (PS) 0, 1 or 2
• Patients must meet protocol-specified laboratory values

You may not qualify if…

• Patients with brain metastases
• 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
• Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
• Female patients who are pregnant, breast feeding
• 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

Where it is running

• 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
• Sammons Cancer Center - Texas Oncology SC-2 — Dallas, Texas, United States
• Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) — San Antonio, Texas, United States
• University of Utah / Huntsman Cancer Institute Huntsman — Salt Lake City, Utah, United States
• University of Wisconsin Univ Wisc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.