Phase I Dose Escalating Study of TKI258

December 17, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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

  • Japan
    • Osaka
      • Takatsuki, Osaka, Japan, 569-8686
        • Novartis Investigative Site
    • Saitama
      • Hidaka, Saitama, Japan, 350-1241
        • Novartis Investigative Site

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TKI258
dose escalation
Drug: TKI258
Other Names:
  • Dovitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) of TKI258
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Antineoplastic activity based on the RECIST criteria
Time Frame: 22 months
22 months

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

September 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTKI258A1101

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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