이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

골수 섬유증 환자의 경구용 TP-3654 연구

2026년 9월 30일 업데이트: Sumitomo Pharma America, Inc.

중간 또는 고위험 원발성 또는 속발성 골수 섬유증 환자에서 경구용 TP-3654의 1/2상, 공개, 용량 증량, 안전성, 약동학 및 약력학 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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)

연구 유형

중재적

등록 (추정된)

240

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 독일
      • Halle, 독일
        • 모병
        • Universitätsmedizin Halle
        • 연락하다:
          • SMPA Investigative Site
      • Lübeck, 독일
        • 모병
        • Universitätsklinikum Schleswig-Holstein
        • 연락하다:
          • SMPA Investigative Site
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294
        • 모병
        • University of Alabama
        • 연락하다:
          • Tiffany Hill
          • 전화번호: 205-934-9591
    • Arizona
      • Tucson, Arizona, 미국, 85724
        • 모병
        • The University of Arizona Cancer Center
        • 연락하다:
    • California
      • Duarte, California, 미국, 91010
        • 모병
        • City of Hope
        • 연락하다:
      • Los Angeles, California, 미국, 90033
        • 모병
        • University of Southern California
        • 연락하다:
      • Newport Beach, California, 미국, 92663
        • 모병
        • Hoag Family Cancer Institute
        • 연락하다:
    • Colorado
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • 모병
        • Yale School of Medicine
        • 연락하다:
    • Florida
      • Gainesville, Florida, 미국, 32608
        • 완전한
        • University of Florida Health Shands Cancer Hospital
      • Miami, Florida, 미국, 33136
        • 모병
        • University of Miami
        • 연락하다:
      • Miami, Florida, 미국, 33176
    • Georgia
      • Atlanta, Georgia, 미국, 30322
    • Illinois
      • Chicago, Illinois, 미국, 60637
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • 모병
        • University of Maryland
        • 연락하다:
          • Maria Baer, MD
          • 전화번호: 410-328-8708
          • 이메일: mbaer@umm.edu
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 연락하다:
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • 모병
        • University of Michigan
        • 연락하다:
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • 모병
        • University of Minnesota
        • 연락하다:
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University of Medicine
        • 연락하다:
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • 모병
        • John Theurer Cancer Center at Hackensack University Medical Center
        • 연락하다:
    • New York
      • Buffalo, New York, 미국, 14263
        • 완전한
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, 미국, 10065
        • 모병
        • Memorial Sloan Kettering Cancer Center
        • 연락하다:
      • New York, New York, 미국, 10029
      • New York, New York, 미국, 10065
        • 모병
        • Weill Cornell Medical Center
        • 연락하다:
      • The Bronx, New York, 미국, 10461
    • North Carolina
      • Durham, North Carolina, 미국, 27710
    • Ohio
      • Columbus, Ohio, 미국, 43210
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • 모병
        • Medical University of South Carolina
        • 연락하다:
    • Tennessee
      • Nashville, Tennessee, 미국, 37232
        • 모병
        • Vanderbilt University
        • 연락하다:
          • SMPA Investigative Site
      • Nashville, Tennessee, 미국, 37203
    • Texas
      • Houston, Texas, 미국, 77054
        • 모병
        • MD Anderson Cancer Center
        • 연락하다:
    • Utah
      • Salt Lake City, Utah, 미국, 84112
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • 모병
        • University of Virginia Cancer Center
        • 연락하다:
    • Washington
      • Seattle, Washington, 미국, 98109
        • 모병
        • University of Washington - Fred Hutchinson Cancer Center
        • 연락하다:
  • 벨기에
      • Antwerp, 벨기에, 2020
        • 모병
        • ZNA Cadix
        • 연락하다:
          • SMPA Investigative Site
      • Antwerp, 벨기에, 2030
        • 모병
        • ZNA Middelheim
        • 연락하다:
          • SMPA Investigative Site
      • Ghent, 벨기에, 9000
        • 모병
        • Universitair Ziekenhuis Gent
        • 연락하다:
          • SMPA Investigative Site
      • Liège, 벨기에, 4000
        • 모병
        • CHU de Liege
        • 연락하다:
          • SMPA Investigative Site
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, 벨기에, 3000
        • 모병
        • University Hospitals Leuven
        • 연락하다:
          • SMPA Investigative Site
  • 스페인
      • Barcelona, 스페인
        • 모병
        • Hospital Universitario y Politecnico La Fe
        • 연락하다:
          • SMPA Investigative Site
      • Barcelona, 스페인
        • 모병
        • Institut Catala d'Oncologia
        • 연락하다:
          • SMPA Investigative Site
      • Salamanca, 스페인
        • 모병
        • Hospital Universitario de Salamanca
        • 연락하다:
          • SMPA Investigative Site
  • 영국
      • Lincoln, 영국
        • 모병
        • Lincoln County Hospital
        • 연락하다:
          • SMPA Investigative Site
      • Lincoln, 영국
        • 모병
        • United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital
        • 연락하다:
          • SMPA Investigative Site
      • London, 영국
        • 모병
        • University College London Hospital's NHS foundation Trust
        • 연락하다:
          • SMPA Investigative Site
      • Oxford, 영국
        • 모병
        • Oxford University Hospitals NHS Foundation
        • 연락하다:
          • SMPA Investigative Site
  • 이탈리아
      • Alessandria, 이탈리아, 15121
        • 모병
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
        • 연락하다:
          • SMPA Investigative Site
      • Aviano, 이탈리아, 33081
        • 모병
        • Istituto Nazionale Tumori, IRCCS Centro di Riferimento Oncologico di Aviano
      • Bologna, 이탈리아, 40138
        • 모병
        • IRCCS Azienda Ospedaliero -Universitaria Di Bologna - Dipartimento Malattie Oncologiche ed Ematologiche - UO Ematologia
        • 연락하다:
          • SMPA Investigative Site
      • Brescia, 이탈리아
        • 모병
        • ASST - Spedali Civili di Brescia
        • 연락하다:
          • SMPA Investigative Site
      • Meldola, 이탈리아, 47014
        • 모병
        • IRCCS istituto Romagnolo per lo studio dei tumori "Dino Amadori"
        • 연락하다:
          • SMPA Investigative Site
      • Milan, 이탈리아, 20122
        • 모병
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • 연락하다:
          • SMPA Investigative Site
      • Torino, 이탈리아, 10126
        • 모병
        • Azienda Ospedaliera Universitaria Citta' Della Salute E della Scienza di Torino
        • 연락하다:
          • SMPA Investigative Site
  • 일본
      • Aichi, 일본
      • Aomori, 일본
        • 모병
        • Aomori Prefectural Central Hospital
        • 연락하다:
      • Chiba, 일본
        • 모병
        • National Cancer Center Hospital East
        • 연락하다:
      • Fukuoka, 일본
      • Hokkaido, 일본
        • 모병
        • Hokkaido University Hospital
        • 연락하다:
      • Kamakura, 일본, 247-8533
      • Miyazaki, 일본
      • Okayama, 일본
        • 모병
        • Okayama University Hospital
        • 연락하다:
      • Osaka, 일본
        • 모병
        • The University of Osaka Hospital
        • 연락하다:
          • Michiko Ichii, MD
          • 전화번호: 06-6879-5111
      • Saitama, 일본
        • 완전한
        • Saitama Medical Center
      • Sendai, 일본
        • 모병
        • Tohoku University Hospital
        • 연락하다:
          • Noriko Fukuhara, MD
          • 전화번호: 022-717-7000
      • Shizuoka, 일본
        • 완전한
        • Shizuoka Cancer Center
      • Tokyo, 일본, 160-0023
        • 모병
        • Tokyo Medical University Hospital
        • 연락하다:
      • Tokyo, 일본
        • 모병
        • Juntendo University Hospital
        • 연락하다:
      • Tokyo, 일본, 179-0072
        • 모병
        • Nerima Hikarigaoka Hospital
        • 연락하다:
      • Tsu, 일본
  • 캐나다
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V6T 1Z3
        • 모병
        • University of British Columbia
        • 연락하다:
          • SMPA Investigative Site
      • Vancouver, British Columbia, 캐나다, V6T 1Z3
        • 모병
        • St. Paul's Hospital Hematology/Oncology Research
        • 연락하다:
    • Ontario
      • Hamilton, Ontario, 캐나다, L8V 5C2
        • 모병
        • Juravinski Cancer Center
        • 연락하다:
          • SMPA Investigative Site
      • Toronto, Ontario, 캐나다, M5G 2M9
        • 모병
        • Princess Margaret Cancer Center
        • 연락하다:
    • Quebec
      • Montreal, Quebec, 캐나다, H3T 1E2
        • 모병
        • Jewish General Hospital
        • 연락하다:
          • SMPA Investigative Site
  • 프랑스
      • Amiens, 프랑스, 80054
        • 모병
        • Centre Hospitalier Universitaire D'Amiens
        • 연락하다:
          • SMPA Investigative Site
      • Angers, 프랑스, 9000
        • 모병
        • CHU Angers
        • 연락하다:
          • SMPA Investigative Site
      • Lyon, 프랑스, 69495
        • 모병
        • Centre Hospitalier Lyon Sud
        • 연락하다:
          • SMPA Investigative Site
      • Nice, 프랑스, 06200
        • 모병
        • Hospitalier Universitaire (CHU) de Nice - Hopital de l'Archet
        • 연락하다:
          • SMPA Investigative Site
      • Nîmes, 프랑스, 30029
        • 모병
        • Institut de cancerologie du Gard
        • 연락하다:
          • SMPA Investigative Site
      • Nîmes, 프랑스
        • 모병
        • Institut de cancerologie du Gard
        • 연락하다:
          • SMPA Investigative Site
      • Paris, 프랑스, 75010
        • 모병
        • Hospital Saint Louis
        • 연락하다:
          • SMPA Investigative Site
      • Poitiers, 프랑스, 86021
        • 모병
        • University Hospital of Poitiers
        • 연락하다:
          • SMPA Investigative Site
      • Villejuif, 프랑스, 94805
        • 모병
        • Institut Gustave Roussy
        • 연락하다:
          • SMPA Investigative Site
  • 호주
      • Adelaide, 호주
        • 모병
        • Icon Cancer Centre (Ashford Cancer Centre Research)
        • 연락하다:
    • South Australia
      • Adelaide, South Australia, 호주
    • Victoria
      • Box Hill, Victoria, 호주
        • 모병
        • Eastern Health Box Hill Hospital
        • 연락하다:
          • SMPA Investigative Site
      • Clayton, Victoria, 호주
        • 모병
        • Monash University
        • 연락하다:
          • SMPA Investigative Site
      • Fitzroy, Victoria, 호주
        • 모병
        • St Vincent's Hospital Melbourne
        • 연락하다:
          • SMPA Investigative Site
      • Melbourne, Victoria, 호주
        • 모병
        • Peter McCallum Center
        • 연락하다:
          • SMPA Investigative Site
      • Richmond, Victoria, 호주
        • 모병
        • Epworth Healthcare
        • 연락하다:
          • SMPA Investigative Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 팔 1: 누비서팁(TP-3654)
의약품: Nusivertib

Oral PIM Inhibitor

다른 이름들:
  • TP-3654
실험적: 2군: 룩소리티닙에 누비서팁(TP-3654) 추가
의약품: Nusivertib

Oral PIM Inhibitor

다른 이름들:
  • TP-3654
의약품: Ruxolitinib

Oral JAK inhibitor

다른 이름들:
  • 자카피어
실험적: 3군: 누비서팁(TP-3654)과 모멜로티닙 병용
의약품: Nusivertib

Oral PIM Inhibitor

다른 이름들:
  • TP-3654
의약품: Momelotinib

Oral JAK inhibitor

다른 이름들:
  • Ojjaara

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Determine the incidence of dose-limiting toxicities (DLTs)
기간: 28 days

Number of participants with DLTs
28 days
Determine the incidence of treatment emergent adverse events
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants achieving objective response by IWG-MRT response criteria
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 hours

The time to reach maximum nuvisertib concentration
24 hours

기타 결과 측정

결과 측정
측정값 설명
기간
골수섬유화 감소 환자 수
기간: 연구가 끝날 때까지 24주마다
연구가 끝날 때까지 24주마다
Nuvisertib 병용군: 기준선 대비 헤모글로빈 ≥1.5 또는 ≥ 2g/dL 증가를 평가합니다.
기간: 치료 시작부터 연구 종료까지
치료 시작부터 연구 종료까지
Nuvisertib 복합군: 적혈구 수혈 독립성 상태 또는 요구 사항 변경 평가
기간: 치료 시작부터 연구 종료까지
치료 시작부터 연구 종료까지
Nuvisertib 단독 요법 : 기준선 혈소판 수 <100 x 10^9/L 환자에서 시간이 지남에 따라 혈소판 수의 변화
기간: 치료 시작부터 연구 종료까지
치료 시작부터 연구 종료까지
Study potential pharmacodynamic (PD) markers of nuvisertib
기간: 12 months

Evaluate exploratory biomarkers, including change in protein phosphorylation and inflammatory cytokines, in peripheral blood samples and bone marrow biopsy samples.
12 months
Establish overall survival
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sumitomo Pharma America, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 12월 16일

기본 완료 (추정된)

2027년 4월 30일

연구 완료 (추정된)

2030년 4월 30일

연구 등록 날짜

최초 제출

2019년 11월 8일

QC 기준을 충족하는 최초 제출

2019년 11월 22일

처음 게시됨 (실제)

2019년 11월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 30일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BBI-TP-3654-102

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다