Clinical Trial: A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase II, Prospective, Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Asian Subjects With Primary Myelofibrosis
Brief Summary: To evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of pacritinib in Asian subjects with myelofibrosis (MF), which includes primary MF (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF).
Detailed Summary:
Sponsor: Baxalta US Inc.
Current Primary Outcome: Proportion of participants achieving a ≥35% reduction in spleen volume [ Time Frame: Baseline to Week 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of participants with ≥50% reduction in total symptom score (TSS) [ Time Frame: Baseline to Week 24 ]Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) TSS 2.0
- Proportion of participants with baseline platelet count <100,000/μL achieving ≥35% reduction in spleen volume [ Time Frame: Baseline to Week 24 ]Measured by MRI or CT scan
- Proportion of participants with baseline platelet count <100,000/μL achieving ≥50% reduction in total symptom score (TSS) [ Time Frame: Baseline to Week 24 ]
- Proportion of participants with baseline platelet count <50,000/μL achieving ≥35% reduction in spleen volume [ Time Frame: Baseline to Week 24 ]Measured by MRI or CT scan
- Proportion of participants with baseline platelet count <50,000/μL achieving ≥50% reduction in total symptom score (TSS) [ Time Frame: Baseline to Week 24 ]
- Clinically significant adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
- Clinically significant changes in laboratory results [ Time Frame: Throughout the study period of approximately 5 years ]
- Clinically significant changes in vital signs [ Time Frame: Throughout the study period of approximately 5 years ]
- Clinically significant changes in electrocardiograms (ECGs) [ Time Frame: Throughout the study period of approximately 5 years ]
- Pacritinib pharmacokinetic (PK) parameter: maximum observed concentration (Cmax) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pacritinib pharmacokinetic (PK) parameter: Time of maximum observed concentration (Tmax) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pacritinib pharmacokinetic (PK) parameter: minimum observed concentration (Cmin) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pacritinib pharmacokinetic (PK) parameter: area under the concentration curve (AUC) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pacritinib pharmacokinetic (PK) parameter: apparent volume of distribution (V/F) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pharmacodynamic parameter: Maximum observed effect (Emax) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pharmacodynamic parameter: time of maximum observed effect (tEmax) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
- Pharmacodynamic parameter: area under the effect curve (AUEC) [ Time Frame: Baseline; weeks 3, 12 & 24 ]
Original Secondary Outcome: Same as current
Information By: Baxalta US Inc.
Dates:
Date Received: October 21, 2015
Date Started: November 2015
Date Completion: August 2020
Last Updated: July 8, 2016
Last Verified: July 2016