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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01421004
First received: August 11, 2011
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Excluding Breast Cancer
Drug: TKI258
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: December 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421004

Locations
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-Siteman Cancer Ctr 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 University of Pittsburgh (SC)
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartitis Pharmaceuticals Novartitis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01421004     History of Changes
Other Study ID Numbers: CTKI258A2128
Study First Received: August 11, 2011
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
cancer
tumors
phase I
crossover
bioequivalence

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014