A Phase 2 Study to Evaluate the Efficacy and Safety of GS-6624 in Adult Subjects With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with Primary myelofibrosis (PMF) and Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis (ET/PV MF). The study is designed as a two stage trial. In the stage 1, patients will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, patients on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Ruxolitinib
- drug : Simtuzumab
Phase: Phase 2
Ages Eligible For Study:
- Must be diagnosed with PMF or post ET/PV MF with intermediate-1, intermediate-2 or high risk disease according to the IWG prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is ? 10 cm below left costal margin by physical exam. - Must have adequate organ function as demonstrated by the following: - ALT (SGPT) and/or AST (SGOT) ? 2.5x upper limit of normal (ULN), or ? 4x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF); - Direct bilirubin ? 1.5 x ULN; or ? 2x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF); - Serum creatinine ? 2.5 mg/dL. 2.5 mg/dL. - In Stage 2, subjects must be on ruxolitinib for at least 8 weeks and on a stable dose for at least 4 weeks. - ECOG performance status (PS) ? 2 - Treatment-related toxicities from prior therapies must have resolved to Grade ? 1 - Women of childbearing potential and men must agree to using one medically approved (ie, mechanical or pharmacological) contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug. Please refer to Section 11 for a definition of female of child bearing potential and a list of acceptable contraceptive methods for this study.