A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

April 30, 2026 updated by: Sumitomo Pharma America, Inc.

A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Arm 1 will enroll patients who have been previously treated and failed on a JAK inhibitor or ineligible to receive treatment with a JAK inhibitor.

Arm 2 will enroll patients who are on a stable dose of ruxolitinib, but who have either lost response or had a suboptimal or plateau in response.

Arm 3 will enroll patients who have been previously treated with a JAK inhibitor (except momelotinib)

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Icon Cancer Centre (Ashford Cancer Centre Research)
        • Contact:
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Box Hill, Victoria, Australia
        • Recruiting
        • Eastern Health Box Hill Hospital
        • Contact:
          • SMPA Investigative Site
      • Clayton, Victoria, Australia
        • Recruiting
        • Monash University
        • Contact:
          • SMPA Investigative Site
      • Melbourne, Victoria, Australia
        • Recruiting
        • Peter McCallum Center
        • Contact:
          • SMPA Investigative Site
      • Richmond, Victoria, Australia
        • Recruiting
        • Epworth Healthcare
        • Contact:
          • SMPA Investigative Site
  • Belgium
      • Antwerp, Belgium, 2020
        • Recruiting
        • ZNA Cadix
        • Contact:
          • SMPA Investigative Site
      • Antwerp, Belgium, 2030
        • Recruiting
        • ZNA Middelheim
        • Contact:
          • SMPA Investigative Site
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
          • SMPA Investigative Site
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liege
        • Contact:
          • SMPA Investigative Site
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:
          • SMPA Investigative Site
  • Canada
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • University of British Columbia
        • Contact:
          • SMPA Investigative Site
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • St. Paul's Hospital Hematology/Oncology Research
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Not yet recruiting
        • Juravinski Cancer Center
        • Contact:
          • SMPA Investigative Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Center
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • SMPA Investigative Site
  • France
      • Amiens, France, 80054
        • Recruiting
        • Centre Hospitalier Universitaire d'Amiens
        • Contact:
          • SMPA Investigative Site
      • Angers, France, 9000
        • Recruiting
        • CHU Angers
        • Contact:
          • SMPA Investigative Site
      • Lyon, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • SMPA Investigative Site
      • Nice, France, 06200
        • Recruiting
        • Hospitalier Universitaire (CHU) de Nice - Hopital de l'Archet
        • Contact:
          • SMPA Investigative Site
      • Nîmes, France, 30029
        • Recruiting
        • Institut de Cancérologie du Gard
        • Contact:
          • SMPA Investigative Site
      • Nîmes, France
        • Recruiting
        • Institut de Cancérologie du Gard
        • Contact:
          • SMPA Investigative Site
      • Paris, France, 75010
        • Recruiting
        • Hospital Saint Louis
        • Contact:
          • SMPA Investigative Site
      • Poitiers, France, 86021
        • Recruiting
        • University hospital of Poitiers
        • Contact:
          • SMPA Investigative Site
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • SMPA Investigative Site
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
        • Contact:
          • SMPA Investigative Site
      • Aviano, Italy, 33081
        • Recruiting
        • Istituto Nazionale Tumori, IRCCS Centro di Riferimento Oncologico di Aviano
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero -Universitaria Di Bologna - Dipartimento Malattie Oncologiche ed Ematologiche - UO Ematologia
        • Contact:
          • SMPA Investigative Site
      • Brescia, Italy
        • Recruiting
        • ASST - Spedali Civili di Brescia
        • Contact:
          • SMPA Investigative Site
      • Meldola, Italy, 47014
        • Recruiting
        • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
        • Contact:
          • SMPA Investigative Site
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
          • SMPA Investigative Site
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliera Universitaria Citta' Della Salute E della Scienza di Torino
        • Contact:
          • SMPA Investigative Site
  • Japan
      • Aichi, Japan
      • Aomori, Japan
        • Recruiting
        • Aomori Prefectural Central Hospital
        • Contact:
      • Chiba, Japan
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Fukuoka, Japan
      • Hokkaido, Japan
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Kamakura, Japan, 247-8533
      • Miyazaki, Japan
      • Okayama, Japan
        • Recruiting
        • Okayama University Hospital
        • Contact:
      • Osaka, Japan
        • Recruiting
        • The University of Osaka Hospital
        • Contact:
          • Michiko Ichii, MD
          • Phone Number: 06-6879-5111
      • Saitama, Japan
      • Sendai, Japan
        • Recruiting
        • Tohoku University Hospital
        • Contact:
          • Noriko Fukuhara, MD
          • Phone Number: 022-717-7000
      • Shizuoka, Japan
        • Completed
        • Shizuoka Cancer Center
      • Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
      • Tokyo, Japan
        • Recruiting
        • Juntendo University Hospital
        • Contact:
      • Tsu, Japan
  • United Kingdom
      • Lincoln, United Kingdom
        • Recruiting
        • Lincoln County Hospital
        • Contact:
          • SMPA Investigative Site
      • Lincoln, United Kingdom
        • Recruiting
        • United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital
        • Contact:
          • SMPA Investigative Site
      • London, United Kingdom
        • Recruiting
        • University College London Hospital's NHS foundation Trust
        • Contact:
          • SMPA Investigative Site
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Foundation
        • Contact:
          • SMPA Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama
        • Contact:
          • Tiffany Hill
          • Phone Number: 205-934-9591
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • The University of Arizona Cancer Center
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Family Cancer Institute
        • Contact:
    • Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Gainesville, Florida, United States, 32608
        • Completed
        • University of Florida Health Shands Cancer Hospital
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
      • Miami, Florida, United States, 33176
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University of Medicine
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
        • Completed
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
      • New York, New York, United States, 10029
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical Center
        • Contact:
      • The Bronx, New York, United States, 10461
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Columbus, Ohio, United States, 43210
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
          • SMPA Investigative Site
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington - Fred Hutchinson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Patients must meet all of the following 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 ≥ 1) using the MF-SAF
  • Dose expansion: At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF

Nuvisertib (TP-3654) + Ruxolitinib Arm:

  • Confirmed pathological diagnosis of PMF or post-PV-MF/post ET- MF and intermediate or high-risk primary or secondary MF
  • On ruxolitinib treatment for ≥ 6 months, and on a stable dose of ruxolitinib (5 to 25 mg BID) for ≥ 8 weeks prior to the first dose of nuvisertib, but has either lost response or had a suboptimal or plateau in response
  • Fulfills the following clinical laboratory parameters:
  • Platelet count ≥ 50 × 10^9/L (without assistance of growth factors or platelet transfusions)
  • ANC ≥ 1 × 109/L without assistance of granulocyte growth factors
  • Peripheral blood blast count < 5% at screening
  • Adequate renal function
  • Adequate hepatic function
  • Adequate coagulation function
  • Splenomegaly (spleen volume of ≥ 450 cm3 by MRI/CT scan) within 2 weeks prior to Cycle 1 Day 1
  • At least 2 symptoms measurable with each score ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0
  • ECOG performance status ≤ 1
  • Life expectancy ≥ 6 months

Nuvisertib (TP-3654) + Momelotinib Arm

  • Confirmed pathological diagnosis of PMF or post-PV-MF/post ET-MF and intermediate or high-risk primary or secondary MF
  • Previously treated with an approved JAK inhibitor (except momelotinib) for PMF or Post-PV/ET MF for ≥ 12 weeks, or ≥ 4 weeks if JAK inhibitor therapy was complicated by a transfusion requirement of ≥ 4 units of red blood cells in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma
  • Fulfills the following clinical laboratory parameters:
  • Anemic, defined as Hb <10 g/dL or requiring RBC transfusion at baseline
  • Platelet count ≥ 50 × 109/L (without assistance of growth factors or platelet transfusions)
  • ANC ≥ 1 × 109/L without assistance of granulocyte growth factors
  • Peripheral blood blast count < 5% at screening
  • Adequate renal function
  • Adequate hepatic function
  • Adequate coagulation function
  • Splenomegaly (spleen volume of ≥ 450 cm3 by MRI/CT scan) within 2 weeks prior to Cycle 1 Day 1
  • At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0
  • ECOG performance status ≤ 1
  • Life expectancy ≥ 6 months

Patients meeting any one of these exclusion criteria will be prohibited from participating in this study:

Nuvisertib (TP-3654) Monotherapy Arm:

  • Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
  • Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or not recovered adequately from from surgery prior to first dose.
  • Splenic irradiation within 6 months prior to Screening or prior splenectomy.
  • Prior allogeneic stem cell transplant within the last 6 months.
  • Eligible for allogeneic bone marrow or stem cell transplantation.
  • Unresolved Grade ≥ 2 non-hematological toxicity related to prior treatment
  • History of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; left ventricular ejection fraction (LVEF) < 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1.
  • Corrected QT interval > 480msec.
  • Prior or concurrent malignancy that could interfere with the investigational regime.
  • Known history of chronic liver disease, e.g. portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 1 week prior to Cycle 1 Day 1.
  • Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)
  • Exhibited allergic reactions or sensitivity to nuvisertib, or similar compound.
  • Medical condition or GI tract surgery that could impair absorption or result in short bowel syndrome with diarrhea.
  • Systemic steroid therapy (>10 mg daily prednisone or equivalent) within 1 week prior to the first dose of study treatment (note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding.
  • Pregnant or breastfeeding
  • Currently receiving any other investigational agent.

Nuvisertib (TP-3654) + Ruxolitinib Arm:

  • Received previous systemic antineoplastic therapy (other than ruxolitinib) or any other experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Note: Prior treatment with nuvisertib is not allowed. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
  • Received systemic steroid therapy (>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited)
  • Known allergic reactions or sensitivity to nuvisertib, or similar compound.
  • Splenic irradiation within 6 months prior to Screening or prior splenectomy
  • Prior allogeneic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).
  • Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible.)
  • Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or have not recovered adequately prior to first dose.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1
  • Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)
  • Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed).
  • Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)
  • History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF <45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1
  • Corrected QTcF of > 480 msec
  • Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention
  • History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding
  • Pregnant or breastfeeding

Nuvisertib (TP-3654) + Momelotinib Arm:

  • Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Notes: Prior treatment with momelotinib or nuvisertib is not allowed; in patients with ongoing JAK inhibitor therapy, ie, ruxolitinib, at screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Patients on a low dose of ruxolitinib (eg, 5 mg QD) may have a reduced taper period or no taper; hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
  • Received systemic steroid therapy (>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited).
  • Known allergic reactions or sensitivity to nuvisertib, momelotinib, or any structurally similar drug, or to any component of the formulations of either study intervention
  • Splenic irradiation within 6 months prior to screening or prior splenectomy
  • Prior allogenic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).
  • Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible).
  • Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or have not recovered adequately from surgery prior to first dose.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1
  • Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)
  • Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed)
  • Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)
  • Presence of Grade ≥ 2 peripheral neuropathy
  • History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF < 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1
  • Corrected QTcF of > 480 msec
  • Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention
  • History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: nuvisertib (TP-3654)
Drug: Nusivertib
Oral PIM Inhibitor
Other Names:
  • TP-3654
Experimental: Arm 2: nuvisertib (TP-3654) added on to ruxolitinib
Drug: Ruxolitinib
Oral JAK inhibitor
Other Names:
  • Jakafi
Drug: Nusivertib
Oral PIM Inhibitor
Other Names:
  • TP-3654
Experimental: Arm 3: nuvisertib (TP-3654) in combination with momelotinib
Drug: Momelotinib
Oral JAK inhibitor
Other Names:
  • Ojjaara
Drug: Nusivertib
Oral PIM Inhibitor
Other Names:
  • TP-3654

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the incidence of dose-limiting toxicities (DLTs)
Time Frame: 28 days
Number of participants with DLTs
28 days
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
From start of treatment to end of study
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)
From start of treatment to end of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants achieving objective response by IWG-MRT response criteria
Time Frame: From start of treatment to end of study
Number of participants achieving complete remission, partial remission, clinical improvement, progressive disease and stable disease.
From start of treatment to end of study
Number of participants who have ≥ 25% spleen volume reduction
Time Frame: Every 12 weeks from cycle 1 day 1 through cycle 19 day 1, and then every 24 weeks therafter during treatment.
Number of participants who have ≥ 25% spleen volume reduction compared to baseline
Every 12 weeks from cycle 1 day 1 through cycle 19 day 1, and then every 24 weeks therafter during treatment.
Number of participants with ≥ 50% improvement in total symptom score (TSS50) at week 24
Time Frame: 24 weeks
Number of participants who have ≥ 50% total symptom score reduction by MFSAF compared to baseline after 24 weeks of treatment.
24 weeks
Determine the change in Patient Global Impression of Change (PGIC) at week 24 through end of study.
Time Frame: After 24 weeks of treatment to end of study
Change in PGIC score
After 24 weeks of treatment to end of study
Determine the incidence of QT interval changes
Time Frame: 25 hours
Changes in QT interval and heart rhythm
25 hours
Establish the half-life (t½) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib
Time Frame: 24 hours
The estimate of time for the nuvisertib concentration or amount to be reduced by half
24 hours
Establish the Area under the plasma concentration versus time curve (AUC) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib
Time Frame: 24 hours
The amount of drug exposure over 24 hours period after administration
24 hours
Establish the Peak Plasma Concentration (Cmax) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib
Time Frame: 24 hours
The maximum nuvisertib concentration after administration
24 hours
Establish the Time of Maximum concentration observed (tmax) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib
Time Frame: 24 hours
The time to reach maximum nuvisertib concentration
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with reduction in bone marrow fibrosis
Time Frame: Every 24 weeks to end of study
Every 24 weeks to end of study
Study potential pharmacodynamic (PD) markers of nuvisertib
Time Frame: 12 months
Evaluate exploratory biomarkers, including change in protein phosphorylation and inflammatory cytokines, in peripheral blood samples and bone marrow biopsy samples.
12 months
Nuvisertib combination arms: Assess the increase in hemoglobin ≥1.5 or ≥ 2 g/dL from baseline
Time Frame: From start of treatment to end of study
From start of treatment to end of study
Nuvisertib combination arms: Assess red blood cell transfusion independence status or any requirement change
Time Frame: From start of treatment to end of study
From start of treatment to end of study
Establish overall survival
Time Frame: From start of treatment to end of study
The time interval from treatment start date to date of death from any cause
From start of treatment to end of study
Nuvisertib monotherapy: Changes in platelet count over time in patients with baseline platelet count < 100 x 10^9/L
Time Frame: From start of treatment to end of study
From start of treatment to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBI-TP-3654-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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