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Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia

This study has been terminated.
(Study was stopped due to time dependent drug accumulation)
Information provided by:
Novartis Identifier:
First received: January 18, 2006
Last updated: June 29, 2010
Last verified: June 2010
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).

Condition Intervention Phase
Acute Myeloid Leukemia Drug: TKI258 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 28 days - dose-escalation; 4 months - dose-expansion ]
  • Dose limiting toxicity [ Time Frame: 28 days - dose-escalation; 4 months - dose-expansion ]
  • Safety profile [ Time Frame: 28 days - dose-escalation; 4 months - dose-expansion ]

Secondary Outcome Measures:
  • Evaluation of plasma pharmacokinetics and pharmacodynamics [ Time Frame: 28 days - dose-escalation; 4 months - dose-expansion ]

Enrollment: 34
Study Start Date: September 2004
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258 - dose escalation
Drug: TKI258
Experimental: TKI258 - dose expansion
Drug: TKI258


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00279773

United States, Texas
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77020
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00279773     History of Changes
Other Study ID Numbers: CTKI258A2102
Study First Received: January 18, 2006
Last Updated: June 29, 2010

Keywords provided by Novartis:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on June 26, 2017