CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0492 (clinicaltrials.gov NCT No: NCT01632904)
Title:Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes
Principal Investigator:Srdan Verstovsek
Treatment Agent:Hydroxyurea; Ruxolitinib
Study Status:Open
Study Description:The goal of this clinical research study is to compare the effects of
ruxolitinib against those of hydroxyurea in patients with polycythemia vera
(PV). The safety of these drugs will also be studied.

Ruxolitinib is designed to block a gene mutation that may be important in
cancer cell growth and survival. This may cause the cancer cells to die.

Hydroxyurea is designed to block cancer cells from dividing. This may cause
the cancer cells to die.

In this study, both drugs are being compared to placebos. A placebo is not a
drug. It looks like the study drug but is not designed to treat any disease or
illness. It is designed to be compared with a study drug to learn if the study
drug has any real effect.

Hide details for General InformationGeneral Information

Disease Group:Myeloproliferative Diseases
Phase of Study:Phase III
Treatment Agents:Hydroxyurea
Ruxolitinib
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:lncyte Corporation
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Srdan Verstovsek
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7305
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults