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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421004
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Excluding Breast Cancer Drug: TKI258 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 500 mg FMI capsule + 250 mg FMI tablet
BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet
Drug: TKI258
Other Name: dovitinib
Experimental: 500 mg TKI258 FMI capsule +250 mg FMI tablet
BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule
Drug: TKI258
Other Name: dovitinib

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421004

United States, California
City of Hope National Medical Center SC-2
Duarte, California, United States, 91010-3000
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States, 90095
University of California San Francisco UCSF (SC)
San Francisco, California, United States, 94101
United States, Florida
Florida Cancer Specialists Sarasota Office
Fort Myers, Florida, United States, 33901
United States, Illinois
Rush University Medical Center Rush 3
Chicago, Illinois, United States, 60612
United States, Missouri
Washington University School of Medicine SC
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center Montefiore Medical Center (SC)
Bronx, New York, United States, 10467
United States, Oklahoma
University of Oklahoma Health Sciences Center OUHSC - SC
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Tennessee
Sarah Cannon Research Institute Sarah Cannon Research (SC)
Nashville, Tennessee, United States, 37203
United States, Texas
Sammons Cancer Center - Texas Oncology SC-2
Dallas, Texas, United States, 78246
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
University of Wisconsin Univ Wisc
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartitis Pharmaceuticals Novartitis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01421004     History of Changes
Other Study ID Numbers: CTKI258A2128
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
phase I