Study of LY2784544 for Patients with Myeloproliferative Neoplasms
Sponsor: Eli Lilly and Company
ClinicalTrials ID:NCT01594723
This clinical trial is testing the effectiveness of a new drug, LY2784544, in treating patients with certain blood disorders called myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and myelofibrosis, especially for those who have not responded well to other treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to see how well the drug LY2784544 works in patients with specific blood disorders known as myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF). The study is particularly focused on patients who have not responded to or cannot tolerate standard treatments, or whose disease has worsened while on a drug called ruxolitinib.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) based on specific medical criteria.
- For PV and ET: Must have tried standard treatments without success or cannot tolerate them.
- For MF: Must meet certain risk criteria or have symptoms like an enlarged spleen.
- Must have a specific genetic marker called JAK2 V617F, except for certain study groups.
- Must be 18 years or older.
- Must agree to participate and sign a consent form.
- Must have good liver, kidney, and bone marrow function based on blood tests.
- Must be able to perform daily activities with minimal assistance.
- Must have stopped previous treatments for MPNs at least 14 days before starting the study, except for certain medications like hydroxyurea and low-dose aspirin.
- Must be willing to follow study procedures and attend all appointments.
- Must agree to use effective birth control during the study and for 3 months after.
- Women must have a negative pregnancy test before starting the study and must not be breastfeeding.
- Must be able to swallow capsules.
- If recently had major surgery, must have recovered well before joining the study.
- For certain study groups, must have shown intolerance or lack of response to ruxolitinib.
Exclusion Criteria
- Currently participating in another clinical trial or have recently left one.
- Have a heart condition that affects the heart's electrical activity.
- Have serious medical conditions that could interfere with the study.
- Taking certain medications that could interact with the study drug.
- Taking blood thinners like warfarin, unless for a specific condition.
- Have had a stem cell transplant.
- Have another type of cancer that could affect study results.
- Have active infections like HIV or hepatitis.
- Have severe heart problems or have had a recent heart attack.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group - Duplicate 2 | 72758 | Rogers | Arkansas |
| Providence St. Joseph's Medical Center | 91505 | Burbank | California |
| Norwalk Hospital | 06856 | Norwalk | Connecticut |
| Lakeland Regional Cancer Center | 33805 | Lakeland | Florida |
| Palm Beach Cancer Institue | 33401 | West Palm Beach | Florida |
| Ingalls Memorial Hospital | 60426 | Harvey | Illinois |
| Indiana Blood & Marrow Transplantation (IBMT) | 46237 | Indianapolis | Indiana |
| Cancer Center of Kansas | 67214 | Wichita | Kansas |
| Greenebaum Comprehensive Cancer Center | 21201 | Baltimore | Maryland |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
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