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Kinase Inhibitor
Pacritinib for Myelodysplastic Syndrome
Phase 1 & 2
Waitlist Available
Led By Alain Mina, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after every cycle (c4d1, c7d1, c10d1, c16d1) and yearly after
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test a new drug, pacritinib, in adults and children with Myelodysplastic syndrome (MDS) or Myelodysplastic/myelop
Who is the study for?
This trial is for children (12-17 years) and adults (18+ years) with blood disorders called Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms. Participants must be able to undergo various medical tests, including a bone marrow biopsy, and commit to an up-to-8-year study period with regular clinic visits.
What is being tested?
The trial is testing pacritinib, a capsule taken orally twice daily in 28-day cycles. It's aimed at treating MDS and MDS/MPN by inhibiting certain enzymes that may affect these conditions. Dosages will vary among participants who are monitored over time through clinic visits and repeated tests.
What are the potential side effects?
While the specific side effects of pacritinib aren't listed here, kinase inhibitors like it can commonly cause fatigue, nausea, diarrhea, muscle pain, rash or changes in blood pressure. Side effects depend on individual reactions to the medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after every cycle (c4d1, c7d1, c10d1, c16d1) and yearly after
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after every cycle (c4d1, c7d1, c10d1, c16d1) and yearly after
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy as measured by Objective Response Rate (ORR) per each risk-based cohort
Recommended phase 2 dose of pacritinib in participants 12-17 years of age
Secondary study objectives
Extended safety of pacritinib
Pharmacokinetic (PK) properties of pacritinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Phase II - AdultExperimental Treatment1 Intervention
Low-risk cohort (cohort 2): Initiated on pacritinib 100 mg BID. After three cycles, pacritinib dose escalated to 200 mg BID, the adult phase II recommended dose, if not in complete remission.High-risk cohort (cohort 3): Initiated on pacritnib 200 mg BID, the adult phase II recommended dose.
Group II: 1/Phase I - PediatricExperimental Treatment1 Intervention
Escalating doses of pacritinib (cohort 1)
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,010 Total Patients Enrolled
Alain Mina, M.D.Principal InvestigatorNational Cancer Institute (NCI)
Rosandra N Kaplan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
6,120 Total Patients Enrolled