Phase 1b Study of PU-H71 for the Treatment of Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), Treated with Ruxolitinib
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: I
Principal Investigator: Gundabolu, Krishna
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03935555?cond=NCT03935555&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures:
(1) Assess Safety, Tolerability and Pharmacokinetics of PU-H71 [ Time Frame: 24 weeks ]
Determine the human exposure PK including Cmax
(2) Assess Safety, Tolerability and Pharmacokinetics of PU-H71 [ Time Frame: 24 weeks ]
Determine the human exposure PK including Tmax
(3) Assess Safety, Tolerability and Pharmacokinetics of PU-H71 [ Time Frame: 24 weeks ]
Determine the human exposure PK including AUC0-t
(4) Assess Safety, Tolerability and Pharmacokinetics of PU-H71 [ Time Frame: 24 weeks ]
Determine the human exposure PK including AUC0-inf
(5) Assess Safety, Tolerability and Pharmacokinetics of PU-H71 [ Time Frame: 24 weeks ]
Determine the human exposure PK including CL
(6) Assess Safety, Tolerability and Pharmacokinetics of PU-H71 [ Time Frame: 24 weeks ]
Determine the human exposure PK including t1/2
(7) Assess Safety and Tolerability of PU-H71 [ Time Frame: 24 weeks ]
Determine the Incidence and severity of AEs as determined by the NCI-CTCAE Version 5.0 and by changes in physical examinations
(8) Assess Safety and Tolerability of PU-H71 [ Time Frame: 24 weeks ]
Determine the Incidence and severity of AEs as determined by the NCI-CTCAE Version 5.0 and by changes in electrocardiograms (ECGs)
(9) Assess Safety and Tolerability of PU-H71 [ Time Frame: 24 weeks ]
Determine the Incidence and severity of AEs as determined by the NCI-CTCAE Version 5.0 and by changes in vital signs
(10) Assess Safety and Tolerability of PU-H71 [ Time Frame: 24 weeks ]
Determine the Incidence and severity of AEs as determined by the NCI-CTCAE Version 5.0 and by changes in clinical laboratory evaluations
(11) Assess treatment response of PU H71 [ Time Frame: 24 weeks ]
Treatment response in myelofibrosis (MF) is to be evaluated using the revised International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
(12) Assess treatment response of PU H71 [ Time Frame: 24 weeks ]
Treatment response in myelofibrosis (MF) is to be evaluated using the revised European LeukemiaNet (ELN) response criteria.