Myeloproliferative Neoplasms Clinical Trial
Official title:
A Phase 2, Open Label Efficacy and Safety Study of Anagrelide Controlled Release (CR) in Subjects With Thrombocytosis Secondary to Essential Thrombocythemia and Other Myeloproliferative Neoplasms (MPN)
Anagrelide is a drug that has been shown to slow down how fast platelets are made in the
bone marrow, and has been approved by the FDA for treating high platelets counts in patients
with bone marrow disorders.
Anagrelide Controlled Release ("CR") is a new preparation of anagrelide that is made to
dissolve more slowly than currently marketed versions of this drug. Because of this, the
anagrelide is taken up into the blood more slowly. Researchers think that this slower
release of the drug could help to lower side effects that might be caused by high blood
levels when the drug dissolves as quickly as it does with the currently marketed product.
The main purposes of this study are to see how well Anagrelide CR can control platelet
counts in patients with high platelet levels, to see what kind of side effects it causes,
and to measure blood levels of the drug.
This is an open-label, single-arm, multicenter, Phase 2 study of anagrelide CR in subjects
with an MPN-related thrombocytosis. Eligible subjects will include those who have not been
previously treated for thrombocytosis or have not received platelet-lowering therapy for at
least 2 weeks prior to study treatment. Each subject will receive anagrelide CR at a
starting dose of 0.5 mg b.i.d. (1.0 mg/day), and is anticipated to continue study treatment
for at least 24 weeks. Subjects who have achieved clinical benefit in the opinion of the
Investigator and who are tolerating the study drug may continue study treatment until they
develop unacceptable toxicity or other discontinuation criteria have been met.
The primary efficacy endpoint will be the proportion of subjects who achieve a platelet
response (CR or PR). The safety and tolerability of study treatment will be assessed by the
frequency and severity of adverse events as determined by NCI Common Terminology Criteria
for Adverse Events (CTCAE) v 4.03. The PK profile of anagrelide CR will be assessed at the
initial (0.5mg b.i.d.) and final titrated dose levels.
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