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Study of Oral Dasatinib in Subjects With Myelodysplastic Syndrome (MDS) and Excess Marrow Blasts

NCT00624585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-12-16

Study results available
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Summary

The main purpose of this study is to learn how patients with myelodysplastic syndrome (MDS) respond to the study drug dasatinib. The study drug, dasatinib, has been approved by the U.S. Food and Drug Administration (FDA) for treatment of leukemia, but has not been approved for the treatment of other kinds of cancer. The use of dasatinib in this study is considered experimental.

Conditions

Interventions

DRUG

Dasatinib

DOSE ESCALATION OF DASATINIB AFTER 8 WEEKS IF ELIGIBLE * Dose Level and Dose of dasatinib: 1. Starting dose (1-8 weeks)= 100 mg orally (po) daily 2. +1 (\<8 weeks if no PR and well tolerated) = 150 mg po daily DOSE MODIFICATION OF DASATINIB * Dose Level and Dose of dasatinib: 1. Starting dose = 100 mg po daily 2. -1 = 70 mg po daily 3. -2 = 50 mg po daily OR * Dose Level and Dose of dasatinib: 1. Starting dose = 150 mg po daily 2. -1 = 120 mg po daily 3. -2 = 90 mg po daily 4. -3 = 50 mg po daily

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Alan List, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624585 on ClinicalTrials.gov