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Phase I Dose Escalating Study of TKI258

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01471548
Collaborator
(none)
31
Enrollment
2
Locations
1
Arm
44
Duration (Months)
15.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
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 :
Sep 1, 2008
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: TKI258

dose escalation

Drug: TKI258
Other Names:
  • Dovitinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose (MTD) of TKI258 [30 days]

    Secondary Outcome Measures

    1. Antineoplastic activity based on the RECIST criteria [22 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Takatsuki Osaka Japan 569-8686
    2 Novartis Investigative Site Hidaka Saitama Japan 350-1241

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01471548
    Other Study ID Numbers:
    • CTKI258A1101
    First Posted:
    Nov 16, 2011
    Last Update Posted:
    Dec 21, 2020
    Last Verified:
    Apr 1, 2016
    Keywords provided by Novartis Pharmaceuticals
    tumor
    cancer
    phase1
    TKI258

    Study Results

    No Results Posted as of Dec 21, 2020