CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Dasatinibdrug
Likely dose
Dasatinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00624585
NCT00624585N/ACompleted
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A Pilot Study of Oral Dasatinib in Subjects With MDS and Excess Marrow Blasts

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Feb 27, 2008·Updated Dec 16, 2013

In Brief

A clinical study evaluating Dasatinib for Myelodysplastic Syndromes. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 27, 2008
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.3 years ago

Interventions

Dasatinibdrug

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