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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279773

Enrollment

Registered

2006-01-20

Start date

2004-09-30

Completion date

Unknown

Last updated

2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute, Myeloid, Leukemia

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).

Interventions

DRUGTKI258

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose	28 days - dose-escalation; 4 months - dose-expansion
Dose limiting toxicity	28 days - dose-escalation; 4 months - dose-expansion
Safety profile	28 days - dose-escalation; 4 months - dose-expansion

Secondary

Measure	Time frame
Evaluation of plasma pharmacokinetics and pharmacodynamics	28 days - dose-escalation; 4 months - dose-expansion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026