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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: TKI258

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279773

CTKI258A2102

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

TKI258 - dose escalation

Experimental group

Description:

Dose-Escalation

Treatment:

Drug: TKI258

TKI258 - dose expansion

Experimental group

Description:

Dose-Expansion

Treatment:

Drug: TKI258