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New treatment option for Polycythemia Vera (PV)
Official title A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT07469891
What this study is testing
What is PRT12396?
PRT12396 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycythemia vera (pv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE(s)). The study consists of a dose-escalation phase followed by a dose-expansion phase to further evaluate selected dose level(s).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception...
- Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria
- Documented presence of a JAK2 V617 mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Estimate life expectancy of ≥12 weeks per investigator assessment.
You likely can't join if
- History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.
- Clinically significant anemia due to nutritional deficiency or hemolytic disorders.
- Active or uncontrolled infection requiring systemic therapy or hospitalization.
- Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or...
- Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or...
- Unresolved toxicity \> Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy ≤ Grade 2.
See the full eligibility criteria
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.
- Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria
- Documented presence of a JAK2 V617 mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Estimate life expectancy of ≥12 weeks per investigator assessment.
- Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence.
- Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)
- History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.
- Clinically significant anemia due to nutritional deficiency or hemolytic disorders.
- Active or uncontrolled infection requiring systemic therapy or hospitalization.
- Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results.
- Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation.
- Unresolved toxicity \> Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy ≤ Grade 2.
- Pregnancy or breastfeeding
- Known sensitivity or contraindication to any component of study, or the excipients of study treatment.
- Prior systemic therapy for PV or MF, prior or planned allogeneic hematopoietic stem-cell transplantation, recent major surgery, prior splenectomy or prior splenic irradiation, or use of hematopoietic growth factors...
- Use of strong or moderate cytochrome P450 (CYP) 3A4 inhibitor or inducer, sensitive CYP3A substrates with narrow therapeutic range, or acid-reducing agents that cannot be discontinued prior to study treatment.
- Participation in another treatment clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Coral Springs, Florida, United States
- Grand Rapids, Michigan, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Coral Springs, Florida, United States; Grand Rapids, Michigan, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.