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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00279773
• Other study ID #: CTKI258A2102
• Status: Terminated
• Phase: Phase 1
• First received: January 18, 2006
• Last updated: June 29, 2010
• Start date: September 2004

Study information

• Verified date: June 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• TKI258

Locations

Country	Name	City	State
United States	The University of Texas, M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		28 days - dose-escalation; 4 months - dose-expansion	Yes
Primary	Dose limiting toxicity		28 days - dose-escalation; 4 months - dose-expansion	Yes
Primary	Safety profile		28 days - dose-escalation; 4 months - dose-expansion	Yes
Secondary	Evaluation of plasma pharmacokinetics and pharmacodynamics		28 days - dose-escalation; 4 months - dose-expansion	Yes