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Kinase Inhibitor

1/Phase I - Pediatric for Myelodysplastic Syndrome

Phase 1 & 2

Waitlist Available

Led By Rosandra N Kaplan, 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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and after every cycle (c4d1, c7d1, c10d1, c16d1) and yearly after for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Extended safety of pacritinib

Pharmacokinetic (PK) properties of pacritinib

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,507 Total Patients Enrolled

Rosandra N Kaplan, M.D.Principal InvestigatorNational Cancer Institute (NCI)

4 Previous Clinical Trials

6,120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements to be considered as a potential candidate for this medical study?

"Individuals eligible for this research study must have a diagnosis of myelodysplastic syndrome and fall within the age range of 12 to 120 years old. The trial aims to recruit a total of 160 participants."

Answered by AI

Are individuals above the age of 45 eligible for recruitment in this medical study?

"Individuals aged 12 and older, up to a maximum of 120 years old, are eligible for participation in this research study."

Answered by AI

Are new patients currently being accepted for enrollment in this medical study?

"Based on information from clinicaltrials.gov, this particular research study is not in the process of enrolling volunteers. Although it was initially listed on 3/17/2024 and recently revised on 3/11/2024, it is currently inactive regarding participant recruitment. However, amidst a pool of 4197 open trials actively seeking candidates, individuals have numerous alternative options to consider for participation at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms

2024. "Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06303193.

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