Phase I Dose Escalating Study of TKI258

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471548
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TKI258 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: TKI258
dose escalation
Drug: TKI258
Other Name: Dovitinib

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of TKI258 [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Antineoplastic activity based on the RECIST criteria [ Time Frame: 22 months ]

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471548

Novartis Investigative Site
Takatsuki, Osaka, Japan, 569-8686
Novartis Investigative Site
Hidaka, Saitama, Japan, 350-1241
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01471548     History of Changes
Other Study ID Numbers: CTKI258A1101
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):