A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Condition(s) studied
Investigational drug(s) / intervention(s)
PRT12396: PRT12396 is an investigational oral capsule administered twice daily at the assigned dose level or RDE. Capsules are swallowed whole with water and may be taken one hour before or two hours after meals.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Dose limiting toxicity (DLT) of PRT12396 — Through cycle 1 (4 weeks)
Incidence of dose limiting toxicities, defined according to protocol-specified criteria - Incidence and severity of Adverse events — Through study completion, an average of 2 years
Incidence and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0 - Adverse Events Leading to Dose Modifications or Discontinuation — Through study completion, an average of 2 years
Incidence of AEs leading to dose reductions, dose interruptions, treatment discontinuations, and clinically significant laboratory abnormalities - Maximum tolerated dose (MTD) and Recommended Dose(s) for Expansion (RDE[s]) of PRT12396 — Through study completion, an average of 2 years
Determination of the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]) based on evaluation of DLTs, safety, and tolerability data
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Ronald Reagan Medical Center | Los Angeles | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| BRCR Global - Coral Springs | Coral Springs | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| START Midwest, LLC | Grand Rapids | Michigan | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office | Philadelphia | Pennsylvania | Recruiting |
| Tennessee Oncology, PLLC - Investigational Drug Services | Nashville | Tennessee | Recruiting |
| Tristar BMT | Nashville | Tennessee | Recruiting |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Monash Health, Monash Medical Centre | Clayton | Victoria | Recruiting |
| One Clinical Research | Nedlands | Western Australia | Recruiting |
| Saint-Louis Hospital | Paris | France | Recruiting |
| Oncopole Claudius Regaud | Toulouse | France | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Clínico Universitario de Valencia | Valencia | Spain | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07469891 on ClinicalTrials.gov ↗ ← All trials in Australia