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A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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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 CenterHouston, Texas  77030