NCT00324077

Brief Summary

The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

February 17, 2016

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

May 9, 2006

Last Update Submit

February 16, 2016

Conditions

Myeloid Leukemia, Chronic, Chronic-Phase

Keywords

Chronic phase chronic myelogenous leukemia (CML)

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.

Secondary Outcomes (7)

  • assess safety and tolerability of dasatinib and imatinib administered in combination throughout study

  • identify dose limiting toxicities

  • characterize plasma pharmacokinetics of dasatinib and imatinib in month 1

  • measure major molecular response rate

  • measure the major cytogenetic response rate

  • +2 more secondary outcomes

Interventions

Dasatinib in combination with imatinibDRUG

Eligibility Criteria

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

You may qualify if:

  • males and females, 18 or older
  • chronic phase Ph+ or BCR-ABL positive CML
  • current complete hematologic response to imatinib
  • lack of major molecular response
  • on imatinib for at least one year
  • on the same imatinib dose for at least 6 months
  • adequate hepatic and renal function

You may not qualify if:

  • History of accelerated or blast phase CML
  • Serious uncontrolled medical disorder or active infection
  • Significant cardiovascular disease or bleeding disorder
  • Concurrent use of medications at risk of causing Torsades de Pointe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Los Angeles, California, United States

Location

Local Institution

San Francisco, California, United States

Location

Local Institution

New York, New York, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

DasatinibImatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazines
0

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

May 9, 2006

First Posted

May 10, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2007

Last Updated

February 17, 2016

Record last verified: 2011-04

Locations

US(3)