A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis
NCT ID: NCT04176198
Last Updated: 2025-10-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
240 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-12-16
Study Completion Date
2030-04-30
Brief Summary
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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.
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Detailed Description
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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)
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)
Conditions
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Myelofibrosis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm 1: nuvisertib (TP-3654)
Group Type
EXPERIMENTAL
Nusivertib
Intervention Type
DRUG
Oral PIM Inhibitor
Arm 2: nuvisertib (TP-3654) added on to ruxolitinib
Group Type
EXPERIMENTAL
Nusivertib
Intervention Type
DRUG
Oral PIM Inhibitor
Ruxolitinib
Intervention Type
DRUG
Oral JAK inhibitor
Arm 3: nuvisertib (TP-3654) in combination with momelotinib
Group Type
EXPERIMENTAL
Nusivertib
Intervention Type
DRUG
Oral PIM Inhibitor
Momelotinib
Intervention Type
DRUG
Oral JAK inhibitor
Interventions
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Nusivertib
Oral PIM Inhibitor
Intervention Type
DRUG
Ruxolitinib
Oral JAK inhibitor
Intervention Type
DRUG
Momelotinib
Oral JAK inhibitor
Intervention Type
DRUG
Other Intervention Names
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TP-3654
Jakafi
Ojjaara
Eligibility Criteria
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Inclusion Criteria
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
* 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
Exclusion Criteria
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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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University of Alabama
Birmingham, Alabama, United States
Site Status
RECRUITING
The University of Arizona Cancer Center
Tucson, Arizona, United States
Site Status
RECRUITING
City of Hope
Duarte, California, United States
Site Status
RECRUITING
University of Southern California
Los Angeles, California, United States
Site Status
RECRUITING
Hoag Family Cancer Institute
Newport Beach, California, United States
Site Status
RECRUITING
Blood Cancer Center
Denver, Colorado, United States
Site Status
RECRUITING
Yale School of Medicine
New Haven, Connecticut, United States
Site Status
NOT_YET_RECRUITING
University of Florida Health Shands Cancer Hospital
Gainesville, Florida, United States
Site Status
COMPLETED
University of Miami
Miami, Florida, United States
Site Status
RECRUITING
Baptist Health - Miami Cancer Institute
Miami, Florida, United States
Site Status
NOT_YET_RECRUITING
Emory University
Atlanta, Georgia, United States
Site Status
NOT_YET_RECRUITING
University of Chicago
Chicago, Illinois, United States
Site Status
RECRUITING
University of Maryland
Baltimore, Maryland, United States
Site Status
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
NOT_YET_RECRUITING
University of Michigan
Ann Arbor, Michigan, United States
Site Status
RECRUITING
University of Minnesota
Minneapolis, Minnesota, United States
Site Status
RECRUITING
Washington University of Medicine
St Louis, Missouri, United States
Site Status
RECRUITING
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Site Status
RECRUITING
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Site Status
COMPLETED
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Site Status
RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
RECRUITING
Weill Cornell Medical Center
New York, New York, United States
Site Status
RECRUITING
Montefiore Cancer Center
The Bronx, New York, United States
Site Status
RECRUITING
Duke Cancer Institute
Durham, North Carolina, United States
Site Status
RECRUITING
Ohio State University
Columbus, Ohio, United States
Site Status
RECRUITING
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
NOT_YET_RECRUITING
Tri-Star Centennial Medical Center
Nashville, Tennessee, United States
Site Status
RECRUITING
Vanderbilt University
Nashville, Tennessee, United States
Site Status
RECRUITING
MD Anderson Cancer Center
Houston, Texas, United States
Site Status
RECRUITING
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Site Status
RECRUITING
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Site Status
RECRUITING
University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington, United States
Site Status
RECRUITING
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Site Status
RECRUITING
Eastern Health Box Hill Hospital
Box Hill, Victoria, Australia
Site Status
RECRUITING
Monash University
Clayton, Victoria, Australia
Site Status
RECRUITING
Peter McCallum Center
Melbourne, Victoria, Australia
Site Status
RECRUITING
Epworth Healthcare
Richmond, Victoria, Australia
Site Status
RECRUITING
Icon Cancer Centre (Ashford Cancer Centre Research)
Adelaide, , Australia
Site Status
RECRUITING
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
Site Status
RECRUITING
ZNA Cadix
Antwerp, , Belgium
Site Status
RECRUITING
ZNA Middelheim
Antwerp, , Belgium
Site Status
RECRUITING
Universitair Ziekenhuis Gent
Ghent, , Belgium
Site Status
RECRUITING
CHU de Liege
Liège, , Belgium
Site Status
NOT_YET_RECRUITING
University of Calgary
Calgary, Alberta, Canada
Site Status
NOT_YET_RECRUITING
St. Paul's Hospital Hematology/Oncology Research
Vancouver, British Columbia, Canada
Site Status
RECRUITING
University of British Columbia
Vancouver, British Columbia, Canada
Site Status
RECRUITING
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Site Status
RECRUITING
Jewish General Hospital
Montreal, Quebec, Canada
Site Status
NOT_YET_RECRUITING
Centre Hospitalier Universitaire D'Amiens
Amiens, , France
Site Status
RECRUITING
CHU Angers
Angers, , France
Site Status
RECRUITING
Centre Hospitalier Lyon Sud
Lyon, , France
Site Status
NOT_YET_RECRUITING
Hospitalier Universitaire (CHU) de Nice - Hopital de l'Archet
Nice, , France
Site Status
RECRUITING
Institut de cancerologie du Gard
Nîmes, , France
Site Status
RECRUITING
Institut de cancerologie du Gard
Nîmes, , France
Site Status
RECRUITING
Hospital Saint Louis
Paris, , France
Site Status
RECRUITING
Institut Gustave Roussy
Villejuif, , France
Site Status
RECRUITING
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Site Status
RECRUITING
Istituto Nazionale Tumori, IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, , Italy
Site Status
NOT_YET_RECRUITING
IRCCS Azienda Ospedaliero -Universitaria Di Bologna - Dipartimento Malattie Oncologiche ed Ematologiche - UO Ematologia
Bologna, , Italy
Site Status
RECRUITING
ASST - Spedali Civili di Brescia
Brescia, , Italy
Site Status
RECRUITING
IRCCS istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, , Italy
Site Status
RECRUITING
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Site Status
RECRUITING
Università degli Studi di Milano-Bicocca
Milan, , Italy
Site Status
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Citta' Della Salute E della Scienza di Torino
Torino, , Italy
Site Status
RECRUITING
Aichi Medical University Hospital
Aichi, , Japan
Site Status
RECRUITING
National Cancer Center Hospital East
Chiba, , Japan
Site Status
RECRUITING
Kyushu University Hospital
Fukuoka, , Japan
Site Status
RECRUITING
Hokkaido University Hospital
Hokkaido, , Japan
Site Status
RECRUITING
University of Miyazaki Hospital
Miyazaki, , Japan
Site Status
RECRUITING
Okayama University Hospital
Okayama, , Japan
Site Status
RECRUITING
The University of Osaka Hospital
Osaka, , Japan
Site Status
RECRUITING
Saitama Medical Center
Saitama, , Japan
Site Status
RECRUITING
Tohoku University Hospital
Sendai, , Japan
Site Status
RECRUITING
Shizuoka Cancer Center
Shizuoka, , Japan
Site Status
COMPLETED
Juntendo University Hospital
Tokyo, , Japan
Site Status
RECRUITING
Mie University Hospital
Tsu, , Japan
Site Status
RECRUITING
Lincoln County Hospital
Lincoln, , United Kingdom
Site Status
RECRUITING
United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital
Lincoln, , United Kingdom
Site Status
RECRUITING
University College London Hospital's NHS foundation Trust
London, , United Kingdom
Site Status
RECRUITING
Oxford University Hospitals NHS Foundation
Oxford, , United Kingdom
Site Status
RECRUITING
Countries
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United States
Australia
Belgium
Canada
France
Italy
Japan
United Kingdom
Central Contacts
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Facility Contacts
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Tiffany Hill
Role: primary
205-934-9591
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
Michiko Ichii, MD
Role: primary
06-6879-5111
Noriko Fukuhara, MD
Role: primary
022-717-7000
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
SMPA Investigative Site
Role: primary
Other Identifiers
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BBI-TP-3654-102
Identifier Type: -
Identifier Source: org_study_id
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