Trial Information
A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Time Frame:
28 days - dose-escalation; 4 months - dose-expansion
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CTKI258A2102
NCT ID:
NCT00279773
Start Date:
September 2004
Completion Date:
Related Keywords:
- Acute Myeloid Leukemia
- Acute
- Myeloid
- Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
The University of Texas, M.D. Anderson Cancer Center |
Houston, Texas 77030 |