Status:
COMPLETED
Phase I Dose Escalating Study of TKI258
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01471548
Start Date
September 1 2008
End Date
May 1 2012
Last Update
December 21 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Takatsuki, Osaka, Japan, 569-8686
2
Novartis Investigative Site
Hidaka, Saitama, Japan, 350-1241