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.
This study seeks to (i) determine a safe and tolerated dose of CYT387 given to patients with PMF, post-PV or post-ET and, (ii) assess the effectiveness of orally-administered CYT387 as a treatment for PMF, post-PV or post-ET.
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 : CYT387
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- Diagnosis of PMF or post-polycythemia Vera (PV) or post-essential Thrombocythemia (ET) MF as per revised World Health Organization (WHO) criteria. - High-risk or Intermediate-2 risk MF (as defined by the International Prognostic Scoring System [IPSS]; Appendix 13.6); or intermediate-I risk MF (IPSS) associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy. - Must be at least 18 years of age with life expectancy of ? 12 weeks. - 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: - Aspartate aminotransferase (AST) or alanine aminotransferase (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 ? 50,000/ÁL - Females of childbearing potential must have a negative pregnancy test within 4 days of initiating study drug.