Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
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|ClinicalTrials.gov Identifier: NCT03123588|
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|MPN (Myeloproliferative Neoplasms)||Drug: Ruxolitinib Drug: Anagrelide Drug: Placebo||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||April 20, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
Anagrelide-placebo administered orally BID
|Active Comparator: Anagrelide||
Anagrelide administered orally at a starting dose of 1 mg BID.
Ruxolitinib-placebo administered orally BID.
- Efficacy of ruxolitinib versus anagrelide as measured by proportion of subjects who achieve platelet and white blood cell (WBC) control [ Time Frame: 52 weeks ]
- Safety and tolerability of ruxolitinib measured by adverse events [ Time Frame: Baseline through 30-37 days after end of treatment, up to 36 months per subject. ]
- Proportion of subjects who achieve complete remission or partial remission based on European LeukemiaNet (ELN) 2013 response criteria [ Time Frame: 32 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123588
|Contact: Incyte Corporation Call Centeremail@example.com|
Show 47 Study Locations
|Study Director:||Albert Assad, MD||Incyte Corporation|