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

Novartis Pharmaceuticals1 site in 1 country34 target enrollmentSeptember 2004

ConditionsAcute Myeloid Leukemia

InterventionsTKI258

DrugsTKI258

Overview

Phase: Phase 1
Intervention: TKI258
Conditions: Acute Myeloid Leukemia
Sponsor: Novartis Pharmaceuticals
Enrollment: 34
Locations: 1
Primary Endpoint: Maximum tolerated dose
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

October 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

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