NCT04176198 · Sumitomo Pharma America, Inc.
A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis
What this study is about
This study is a Phase 1/2, conducted at multiple hospitals, gradually increasing doses, where both patients and doctors know the treatment given trial to assess safety, tolerability, how the drug moves through the body and how the drug affects the body of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
View original scientific description
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
Interventions
DRUG
Nusivertib
Oral PIM Inhibitor
DRUG
Ruxolitinib
Oral JAK inhibitor
DRUG
Momelotinib
Oral JAK inhibitor
Primary outcome measures
Determine the incidence of dose-limiting toxicities (DLTs)
Time frame: 28 days
Number of participants with DLTs
Determine the incidence of treatment emergent adverse events
Time frame: From start of treatment to end of study
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Assess patients for any evidence of preliminary activity by determining the number of patients with ≥ 35% spleen volume reduction (SVR35)
Time frame: From start of treatment to end of study
Number of participants with ≥ 35% spleen volume reduction (SVR35)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- to be eligible: Nuvisertib (TP-3654) Monotherapy Arm:
- Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF and intermediate or high-risk primary or secondary MF
- Previously treated with JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor
- Fulfill the following clinical laboratory parameters:
- Platelet count ≥ 25 x 10\^9 /L, without assistance of growth factors or platelet transfusions
- ANC ≥ 1 x 10\^9/L without assistance of granulocyte growth factors
- Peripheral blood blast count \< 5%
- ECOG performance status ≤ 1
- Life expectancy ≥ 6 months
- Adequate renal function
- Adequate hepatic function
- Adequate coagulation function
- Splenomegaly (spleen volume of ≥ 450 cm3 by MRI or CT scan) within 2 weeks prior to Cycle 1 Day 1.
- Dose escalation: At least 2 symptoms measurable (score
Where
- Birmingham, Alabama
- Tucson, Arizona
- Duarte, California
- Los Angeles, California
- Newport Beach, California
- Denver, Colorado
- New Haven, Connecticut
- Gainesville, Florida
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
And 16 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations