Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT02125318
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT02125318
Study Brief:
Protocol Section:
NCT02125318