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CompletedNCT01471548Updated Dec 21, 2020

Phase I Dose Escalating Study of TKI258

A Phase 1 interventional study of TKI258 in Advanced Solid Tumors, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Advanced Solid Tumors

Keywords

  • tumor
  • cancer
  • phase1
  • TKI258
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    TKI258

    dose escalation

    Drug: TKI258

Interventions

  • DrugTKI258

    Also known as: Dovitinib

06

What researchers measure

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

07

Study locations

2 sites
  • Novartis Investigative Site
    Takatsuki, Osaka 569-8686, Japan
  • Novartis Investigative Site
    Hidaka, Saitama 350-1241, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01471548
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 16, 2011
Start date
Sep 2008
Primary completion
May 2012
Completion
May 2012
Last update
Dec 21, 2020

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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