Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
- Registration Number
- NCT00279773
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Confirmed diagnosis of Acute Myeloid Leukemia
- Eighteen years of age or older
- Life expectancy of at least 2 months
Exclusion Criteria
- Intracranial disease or epidural disease
- Clinically significant cardiac disease
- Diabetes mellitus uncontrolled with medication
- Pregnant or breast feeding women
- Dementia or altered mental status
- Known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands
- Previous pericarditis
- Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TKI258 - dose escalation TKI258 Dose-Escalation TKI258 - dose expansion TKI258 Dose-Expansion
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 28 days - dose-escalation; 4 months - dose-expansion Dose limiting toxicity 28 days - dose-escalation; 4 months - dose-expansion Safety profile 28 days - dose-escalation; 4 months - dose-expansion
- Secondary Outcome Measures
Name Time Method Evaluation of plasma pharmacokinetics and pharmacodynamics 28 days - dose-escalation; 4 months - dose-expansion
Trial Locations
- Locations (1)
The University of Texas, M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States