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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)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00279773
First received: January 18, 2006
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity [ Time Frame: 28 days - dose-escalation; 4 months - dose-expansion ] [ Designated as safety issue: Yes ]
  • Safety profile [ Time Frame: 28 days - dose-escalation; 4 months - dose-expansion ] [ Designated as safety issue: Yes ]

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

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
Dose-Escalation
Drug: TKI258
Experimental: TKI258 - dose expansion
Dose-Expansion
Drug: TKI258

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00279773

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00279773     History of Changes
Other Study ID Numbers: CTKI258A2102
Study First Received: January 18, 2006
Last Updated: June 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Acute
Myeloid
Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014