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 : Completed
First Posted : April 21, 2017
Last Update Posted : November 10, 2020
|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)|
|Actual Enrollment :||12 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|
|Actual Primary Completion Date :||August 3, 2020|
|Actual Study Completion Date :||August 3, 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123588
|Study Director:||Albert Assad, MD||Incyte Corporation|