A Phase II, Open-Label Extension Study Evaluating the Long Term Safety, Tolerability & Efficacy of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
This extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 will be evaluated.
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 : Momelotinib
Phase: Phase 2
Ages Eligible For Study:
- Patients must have completed at least 9 cycles of treatment on the core study 'A Phase I/II, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (CCL09101)' and achieved stable disease (SD), clinical improvement (CI), partial remission (PR) or complete remission (CR) using the International Working Group consensus criteria for treatment responses in myelofibrosis with myeloid metaplasia (IWG-MRT; Tefferi et al., 2006) - Must be able to provide informed consent and be willing to sign an informed consent form. - Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. - Must have evidence of acceptable organ function within 7 days of initiating study drug as evidenced by the following: - SGOT (AST) or SGPT (ALT) <= 2.5 x upper limit of normal (ULN) (or <= 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis) - Bilirubin <= 2.0 x ULN or direct bilirubin < 1.0 - Serum creatinine <= 2.5 x ULN - Absolute neutrophil count >= 500/ÁL - Platelet count >= to 20,000/ÁL - Females of childbearing potential must have a negative pregnancy test within 4 days of entering the extension protocol.