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Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

NCT03123588 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-19

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.

Conditions

  • MPN (Myeloproliferative Neoplasms)

Interventions

DRUG

Ruxolitinib

Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.

DRUG

Anagrelide

Anagrelide administered orally at a starting dose of 1 mg BID.

DRUG

Placebo

Anagrelide-placebo administered orally BID

DRUG

Placebo

Ruxolitinib-placebo administered orally BID.

Sponsors & Collaborators

Principal Investigators

  • Albert Assad, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2020-08-03
Completion
2020-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03123588 on ClinicalTrials.gov