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Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01155713
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

June 30, 2010
July 2, 2010
May 3, 2016
July 2010
November 2013   (Final data collection date for primary outcome measure)
  • 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) ]
  • Determine the effect of food on the bioavailability of TKI258 [ Time Frame: food effect (22 days) ]
Same as current
Complete list of historical versions of study NCT01155713 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. [ Time Frame: Every 8 weeks until progression of disease ]
Same as current
Not Provided
Not Provided
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
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
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasm
  • Cancer
  • Tumors
Drug: TKI258
Other Name: Dovitinib
  • Experimental: Arm 1 - TKI258 - bioavailability
    Intervention: Drug: TKI258
  • Experimental: TKI258 - food effect
    Intervention: Drug: TKI258
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2013
November 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP