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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00279773
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: TKI258	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TKI258 - dose escalation Dose-Escalation	Drug: TKI258
Experimental: TKI258 - dose expansion Dose-Expansion	Drug: TKI258

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose [28 days - dose-escalation; 4 months - dose-expansion]

2. Dose limiting toxicity [28 days - dose-escalation; 4 months - dose-expansion]

3. Safety profile [28 days - dose-escalation; 4 months - dose-expansion]

Secondary Outcome Measures

1. Evaluation of plasma pharmacokinetics and pharmacodynamics [28 days - dose-escalation; 4 months - dose-expansion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas, M.D. Anderson Cancer Center	Houston	Texas	United States	77020

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00279773
• Other Study ID Numbers: CTKI258A2102
• First Posted: Jan 20, 2006
• Last Update Posted: Jun 30, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Acute; Myeloid; Leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Jun 30, 2010