A Study of Anagrelide Controlled Release (GALE-401) in Patients With High Platelet Counts Due to Bone Marrow Disorders
Public ClinicalTrials.gov record NCT02125318. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02125318
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2014
- Primary completion
- Apr 30, 2016
- Completion
- Apr 30, 2016
- Last update posted
- Feb 26, 2017
2014 – 2016
United States locations
- U.S. sites
- 11
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| East Valley Hematology and Oncology Medical Group | Burbank | California | 91505 | — |
| California Cancer Associates for Research & Excellence (cCARE) | Encinitas | California | 92024 | — |
| California Cancer Associates for Research & Excellence (cCARE) | Escondido | California | 92025 | — |
| California Cancer Associates For Research and Excellence | Fresno | California | 93720 | — |
| Innovative Medical Research of South Florida, Inc. | Aventura | Florida | 33180 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Gettysburg Cancer Center | Hillsdale | Pennsylvania | 17325 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Cancer Care Centers of South Texas | New Braunfels | Texas | 78130 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02125318, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2017 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02125318 live on ClinicalTrials.gov.