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OpenTrials
Completed

NCT Number: NCT01471548

Phase I Dose Escalating Study of TKI258

The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Takatsuki, Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent must be obtained prior to any screening procedures
  • Advanced solid tumors
  • Agreement to remaining hospitalized
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
  • Demonstrate the specific hematological /blood chemistry laboratory values

Exclusion criteria

  • Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
  • Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
  • Patients with CNS and/or leptomeningeal disease metastases
  • Presence or history of thromboembolic or cerebrovascular events
  • Impaired cardiac function or clinically significant cardiac disease
  • Malabsorption syndrome or uncontrolled gastrointestinal toxicities
  • Patients known to be HIV- or HBV- or HCV- positive
  • Patients with acute or chronic uncontrolled infection
  • Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
  • Patients who have been receiving anticoagulant therapy
  • Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
  • Patients who have been administering concomitant medication which may prolong the QTc interval
  • Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
  • Patients with a large volume of ascitic and/or pleural fluid which requires drainage
  • Patients with any bone fractures
  • Deemed otherwise unsuitable by the investigator

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

TKI258

Drug

Other names: Dovitinib

Primary outcomes

  1. Maximum tolerated dose (MTD) of TKI258

    Time frame: 30 days

Secondary outcomes

  1. Antineoplastic activity based on the RECIST criteria

    Time frame: 22 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2011
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.

Published trials that share one or more normalized conditions with this study.