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Trial record 47 of 48 for:    Dovitinib

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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE June 30, 2010
First Posted Date  ICMJE July 2, 2010
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01155713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm
  • Cancer
  • Tumors
Intervention  ICMJE Drug: TKI258
Other Name: Dovitinib
Study Arms  ICMJE
  • Experimental: Arm 1 - TKI258 - bioavailability
    Intervention: Drug: TKI258
  • Experimental: TKI258 - food effect
    Intervention: Drug: TKI258
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2013)
63
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2010)
46
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01155713
Other Study ID Numbers  ICMJE CTKI258A2116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2016

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