NCT03123588

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

A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-11-14
• Primary completion: 2020-08-03
• Completion: 2020-08-03
• First posted: 2017-04-21
• Last updated: 2021-11-19
• Results posted: 2021-11-19

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study