NCT00279773

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

June 30, 2010

Status Verified

June 1, 2010

Enrollment Period

3.1 years

First QC Date

January 18, 2006

Last Update Submit

June 29, 2010

Conditions

Acute Myeloid Leukemia

Keywords

AcuteMyeloidLeukemia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Evaluation of plasma pharmacokinetics and pharmacodynamics

    28 days - dose-escalation; 4 months - dose-expansion

Study Arms (2)

TKI258 - dose escalation

EXPERIMENTAL

Dose-Escalation

Drug: TKI258

TKI258 - dose expansion

EXPERIMENTAL

Dose-Expansion

Drug: TKI258

Interventions

TKI258DRUG
TKI258 - dose escalationTKI258 - dose expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of Acute Myeloid Leukemia
  • Eighteen years of age or older
  • Life expectancy of at least 2 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas, M.D. Anderson Cancer Center

Houston, Texas, 77020, United States

Location

Related Publications (1)

  • Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.

    PMID: 23400739DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

September 1, 2004

Primary Completion

October 1, 2007

Last Updated

June 30, 2010

Record last verified: 2010-06

Locations

US(1)