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

December 17, 2020 updated by: Novartis Pharmaceuticals

A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258, 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Cancer Dept
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah / Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an advanced solid tumor, except breast cancer,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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TKI258 - bioavailability
Drug: TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
Other Names:
  • dovitinib
Experimental: TKI258 - food
Drug: TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
Other Names:
  • dovitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the relative bioavailability of the final market image form of TKI258 (monohydrate capsules) as compared to the clinical service form of TKI258 (anhydrate capsules)
Time Frame: 9 days
9 days
Determine the effect of food on the bioavailability of TKI258
Time Frame: 22 days
22 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors.
Time Frame: Every 8 weeks until progression of disease
Every 8 weeks until progression of disease
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
Up to 28 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTKI258A2112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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