Back to resultsSafety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TKI258
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute, Myeloid, Leukemia
Eligibility Criteria
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
Sites / Locations
- The University of Texas, M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TKI258 - dose escalation
TKI258 - dose expansion
Arm Description
Dose-Escalation
Dose-Expansion
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Dose limiting toxicity
Safety profile
Secondary Outcome Measures
Evaluation of plasma pharmacokinetics and pharmacodynamics
Full Information
NCT ID
NCT00279773
First Posted
January 18, 2006
Last Updated
June 29, 2010
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00279773
Brief Title
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
Official Title
A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to time dependent drug accumulation
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute, Myeloid, Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TKI258 - dose escalation
Arm Type
Experimental
Arm Description
Dose-Escalation
Arm Title
TKI258 - dose expansion
Arm Type
Experimental
Arm Description
Dose-Expansion
Intervention Type
Drug
Intervention Name(s)
TKI258
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
28 days - dose-escalation; 4 months - dose-expansion
Title
Dose limiting toxicity
Time Frame
28 days - dose-escalation; 4 months - dose-expansion
Title
Safety profile
Time Frame
28 days - dose-escalation; 4 months - dose-expansion
Secondary Outcome Measure Information:
Title
Evaluation of plasma pharmacokinetics and pharmacodynamics
Time Frame
28 days - dose-escalation; 4 months - dose-expansion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
The University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77020
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23400739
Citation
Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.
Results Reference
derived
Learn more about this trial
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
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