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Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia

NCT02047149 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-09-30

No results posted yet for this study

Summary

Prospective nonrandomized phase I study

The purpose of this study is to determine safety and efficacy of zileuton when added to dasatinib in patients with chronic myelogenous leukemia (CML).

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DRUG

Zileuton (Zyflo®) Dasatinib (Sprycel®)

To determine the maximum dose of zileuton/dasatinib in subjects with CML

DRUG

Dosing with Zileuton/Dasatinib in CML

Three dose levels of daily zileuton will be studied in conjunction with dasatinib to define the MTD

DRUG

Daily dosing of Zileuton/Dasatinib

Three dose levels of daily zileuton will be studied in conjunction with dasatinib to define the MTD

DRUG

Daily dosing with Zileuton/Dasatinib for CML

Three dose levels of daily zileuton will be studied in conjunction with dasatinib to define the MTD

Sponsors & Collaborators

Principal Investigators

  • Jan Cerny, MD, PhD · University of Massachusetts, Worcester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT02047149 on ClinicalTrials.gov