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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01155713
First received: June 30, 2010
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Neoplasm
Cancer
Tumors
Drug: TKI258
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Determine the effect of food on the bioavailability of TKI258 [ Time Frame: food effect (22 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. [ Time Frame: Every 8 weeks until progression of disease ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - TKI258 - bioavailability Drug: TKI258
Other Name: Dovitinib
Experimental: TKI258 - food effect 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:

  • 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

  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: NCT01155713

Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01155713     History of Changes
Other Study ID Numbers: CTKI258A2116
Study First Received: June 30, 2010
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Neoplasms
Cancer
Tumors
Administration, oral
Capsules
CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258,
Bioavailability,
Food

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014