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Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult 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: NCT01155713
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : December 21, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.

Condition or disease Intervention/treatment Phase
Neoplasm Cancer Tumors Drug: TKI258 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors
Study Start Date : July 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Arm 1 - TKI258 - bioavailability Drug: TKI258
Other Name: Dovitinib

Experimental: TKI258 - food effect Drug: TKI258
Other Name: Dovitinib

Primary Outcome Measures :
  1. Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules) [ Time Frame: relative bioavailability (9 days) ]
  2. Determine the effect of food on the bioavailability of TKI258 [ Time Frame: food effect (22 days) ]

Secondary Outcome Measures :
  1. Characterize the safety and tolerability of TKI258, including acute and chronic toxicities. [ Time Frame: Up to 28 days after the last dose of study drug ]
  2. Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. [ Time Frame: Every 8 weeks until progression of disease ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists
  • World Health Organization (WHO) performance status ≤ 2
  • Patient must meet protocol-specified laboratory values

Exclusion Criteria:

  • Patients with brain cancer
  • 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
  • Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control

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): NCT01155713

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United States, Arizona
Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
Scottsdale, Arizona, United States, 85258
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Research Institute Sarah Cannon Research Instit
Nashville, Tennessee, United States, 37203
United States, Utah
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01155713    
Other Study ID Numbers: CTKI258A2116
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: May 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Administration, oral
CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258,
Additional relevant MeSH terms:
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