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| ID | Type | Description | Link |
|---|---|---|---|
| I3X-MC-JHTC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine a dose of LY2784544 that may be safely administered to participants with myeloproliferative neoplasms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY2784544 Dosing Regimen A | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days. |
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| Part A: LY2784544 Dosing Regimen B | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days. |
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| Part B: LY2784544 Dosing Regimen A | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days. |
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| Part B: LY2784544 Dosing Regimen B | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2784544 | Drug | LY2784544 will be taken by mouth per a specified schedule. Each cycle is 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with LY2784544 dose limiting toxicities (DLT) | Baseline through Cycle 1 in Part A (28 day cycles) | |
| Recommended dose range and regimen for Phase 2 studies | Baseline through Cycle 1 in Part B (28 day cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of LY2784544: Maximum concentration (Cmax) | Cycle 1 in Part A and Part B (28 day cycles) | |
| Pharmacokinetics of LY2784544: Area under the concentration-time curve (AUC) | Cycle 1 in Part A and Part B (28 day cycles) |
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Inclusion Criteria:
Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF, primary or secondary) PV and ET participants must have failed or are intolerant of standard therapies or refuse to take standard medications
MF participants must meet at least one of the following criteria:
All participants must meet the following criteria:
Exclusion Criteria:
Potential participants may not be included in the study if any of the following apply during screening:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | Alabama | 35249 |
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| International Working Group (IWG) response | Baseline through last Cycle in Part A and Part B (28 day cycles) |
| Dynamic International Prognostic Scoring System (DIPSS) Plus | Baseline through last Cycle in Part A and Part B (28 day cycles) |
| Change in symptom burden as assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) | Baseline, Last Cycle in Part A and Part B |
| Change in Myeloproliferative Neoplasm (MPN) Physician Symptom Assessment | Baseline, Last Cycle in Part A and Part B |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Scottsdale | Arizona | 85259 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fayetteville | Arkansas | 72703 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Washington D.C. | District of Columbia | 20007 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jacksonville | Florida | 32224 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Honolulu | Hawaii | 96813 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Charleston | South Carolina | 29425 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salt Lake City | Utah | 84132 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| D013920 | Thrombocythemia, Essential |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C581039 | LY2784544 |
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