Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2008-09-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TKI258
dose escalation
TKI258
Interventions
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TKI258
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Hidaka, Saitama, Japan
Countries
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Related Links
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Results for CTKI258A1101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CTKI258A1101
Identifier Type: -
Identifier Source: org_study_id