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Completed

NCT Number: NCT01030055

Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult 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

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Key information

Conditions

Neoplasms Cancer Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope National Medical Center, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TKI258 (dovitinib)

Drug

bioavailability (anhydrate capsules) food (monohydrae capsules)

Other names: dovitinib

Primary outcomes

  1. 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

  2. Determine the effect of food on the bioavailability of TKI258

    Time frame: 22 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2009
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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