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| ID | Type | Description | Link |
|---|---|---|---|
| I3X-MC-JHTA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find out the safe dose range of the study drug in patients with myeloproliferative disorders.
The purpose of the study is to learn:
The planned duration of the study is not fixed. The length of time patients participate in the study will be determined by the investigator/study doctor.
Part A of the study is to determine the dose of the study drug. Part A is divided into two sections, A1 and A2. In Part A1, patients will be given study drug without a lead-in period. In Parts A2 and B, patients will have a lead-in period of 2 or 4 weeks with a low dose of LY2784544 prior to taking a higher dose of LY2784544. Part B of the study is to confirm the safety of the dose and schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2784544 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2784544 | Drug | LY2784544 will be supplied as a capsule. The study drug will be taken by mouth daily while the patient is on study. In this study, different patients will be treated at different doses of LY2784544 until reaching the highest dose that patients can tolerate. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of a recommended Phase 2 dosing regimen | Time of first dose until last dose | |
| Number of participants with clinical significant effects | Time of first dose until last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary pharmacokinetics of LY2784544 (Cmax) | Part A1: Day 1,2,15, and 29; Part A2: Day 7, 14, 21, 28, 29, 56, and 57; Part B: Day 1, 29, 57, and 113 | |
| Preliminary pharmacokinetics of LY2784544 (AUC) | Part A1: Day 1,2,15, and 29; Part A2: Day 7, 14, 21, 28, 29, 56, and 57; Part B: Day 1, 29, 57, and 113 |
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Inclusion Criteria:
A. PV: has failed or is intolerant of standard therapies or refuses to take standard medications
B. ET: has failed or is intolerant of standard therapies or refuses to take standard medications
C. MF (patients with MF must meet at least one of the following):
i. has intermediate or high-risk MF according to the Lille scoring system; or
ii. has symptomatic MF with spleen greater than 10 cm below left costal margin; or
iii. has post-polycythemic MF; or
iv. has post-ET MF
Exclusion Criteria:
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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. | Houston | Texas | 77030 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28934680 | Derived | Verstovsek S, Mesa RA, Salama ME, Li L, Pitou C, Nunes FP, Price GL, Giles JL, D'Souza DN, Walgren RA, Prchal JT. A phase 1 study of the Janus kinase 2 (JAK2)V617F inhibitor, gandotinib (LY2784544), in patients with primary myelofibrosis, polycythemia vera, and essential thrombocythemia. Leuk Res. 2017 Oct;61:89-95. doi: 10.1016/j.leukres.2017.08.010. Epub 2017 Aug 31. |
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| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D013920 | Thrombocythemia, Essential |
| D011087 | Polycythemia Vera |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001778 | Blood Coagulation Disorders |
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| ID | Term |
|---|---|
| C581039 | LY2784544 |
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| Malignant clone burden | Part A1: Baseline (2 times), Weeks 13, 21 and every 6 months while patient is on study; Parts A2 and B: Baseline (2 times), Weeks 5, 8, 17, 25 and every 6 months while patient is on study |
| 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 |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |