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The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB1518 | Drug | SB1518 taken orally daily for 28 consecutive days in a 28-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily | Throughout the study | |
| Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF | Throughout the study | |
| Assess the pharmacokinetic profile of SB1518 | Throughout the study | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| John Seymour, M.D. | Peter MacCallum Cancer Centre, Australia | Principal Investigator |
| Andrew Roberts, M.D. | Melbourne Health | Principal Investigator |
| Bik To, MD | Royal Adelaide Hospital | Principal Investigator |
| Rami Komrokji, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Martha Wadleigh, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Ruben Mesa, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25762180 | Derived | Komrokji RS, Seymour JF, Roberts AW, Wadleigh M, To LB, Scherber R, Turba E, Dorr A, Zhu J, Wang L, Granston T, Campbell MS, Mesa RA. Results of a phase 2 study of pacritinib (SB1518), a JAK2/JAK2(V617F) inhibitor, in patients with myelofibrosis. Blood. 2015 Apr 23;125(17):2649-55. doi: 10.1182/blood-2013-02-484832. Epub 2015 Mar 11. |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D009196 | Myeloproliferative Disorders |
| D011087 | Polycythemia Vera |
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019046 | Bone Marrow Neoplasms |
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| ID | Term |
|---|---|
| C561234 | 11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene |
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| Assess the pharmacodynamic profile of SB1518 |
| Throughout the study |
| Tampa |
| Florida |
| 33612 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3002 | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |