Evaluating Safety ,Tolerability, Pharmacokinetic,Efficacy of WJ01024 or WJ01024 Combined With Ruxolitinib in Patients With Myelofibrosis
A Phase I Clinical Study Evaluating the Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Oral Administration of WJ01024 as a Monotherapy and in Combination With Ruxolitinib in Patients With Myelofibrosis
This is a Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and preliminary efficacy of oral WJ01024 administered as monotherapy and in combination with ruxolitinib in patients with myelofibrosis(MF). The study will be conducted in two phases: Phase IA and Phase IB.
Phase IA is a dose-escalation and dose-expansion study of WJ01024 monotherapy in patients with MF after failure of JAK inhibitor (JAKi) therapy (relapsed/refractory/intolerant). Phase IB is a dose-escalation and dose-expansion study of WJ01024 in combination with ruxolitinib in JAKi-naïve patients with intermediate- or high-risk MF.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Shuai Guo
- 전화번호: 15902401702
- 이메일: sguo@wigenbio.com
연구 장소
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Henan
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Zhengzhou, Henan, 중국, 450000
- 모병
- Henan Cancer Hospital
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연락하다:
- Zhou Hu, PhD.
- 전화번호: 13939068863
- 이메일: papertigerhu@163.com
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수석 연구원:
- Zhou Hu, Ph.D.
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- The subjects voluntarily participated in this study after obtaining full informed consent and signed the informed consent form.
- Age ≥18 years old, gender not limited;
- Patients diagnosed with primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or patients diagnosed with post-essential thrombocythemia MF (PET-MF) or post-polycythemia vera MF (PPV-MF) according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria;
- Patients evaluated as intermediate-1, intermediate-2, or high-risk according to the International Prognostic System (DIPSS) scoring system;;
- Expected life expectancy is ≥ 24 weeks;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2 ;
- No planned for stem cell transplantation in the near future.
- Splenomegaly: Palpation of the spleen margin reaches or exceeds at least 5cm below the costal margin (the distance from the costal margin to the farthest point of the spleen protrusion), or spleen volume ≥450cm ³ by CT or MRI.
Adequate hematological and organ function within 7 days before the first administration of the study drug (no RBC transfusion, growth factors, colony-stimulating factors, platelet-generating factors ,or platelet transfusion within 14 days before the testing) :
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelet count ≥75×109/L(Phase IA); Platelet count ≥100×109/L(Phase IB); Hemoglobin ≥ 8.0g /dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Creatinine ≤1.5×ULN.
- For women of childbearing age, within 7 days before the first administration, if the serum pregnancy test is confirmed to be negative and they agree to use effective contraceptive measures during the study drug period and within 90 days after the last administration. For male subjects whose sexual partners are women of childbearing age, they must agree to take effective contraceptive measures during the use of the study drug and within 90 days after the last administration.
Exclusion Criteria:
- Peripheral blood blasts >5% or Bone marrow blasts >10%.
- Previous treatment with XPO1 inhibitors.
- Unable to cooperate with or unable to perform MRI or CT scans as deemed necessary by sponsor and investigator
- Treatment with strong CYP3A inhibitors or inducers within 14 days prior to initial administration"
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: WJ01024 tablet
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5-20mg BID (dosage per investigator judgement)
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
DLT
기간: 12 months
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Incidence of DLT
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12 months
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AE
기간: 4 years
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incidence and severity of adverse events(AEs) and serious adverse events(SAEs),as well as abnormal changes in clinical significance laboratory tests and other examinations
|
4 years
|
|
MTD
기간: 12 months
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Evaluate the Maximum tolerated dose
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12 months
|
|
RP2D
기간: 12 months
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Evaluate the recommended dose for phase II
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12 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetic (PK) Parameter
기간: 1.5 years
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The blood concentration of WJ01024
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1.5 years
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SVR35
기간: 4 years
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Percentage of subjects with spleen volume reduction of ≥35% (SVR35)
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4 years
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Score in MPN-SAF-TSS
기간: 4 years
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Percentage reduction in Total Symptom Score(TSS) and proportion of subjects achieving ≥50% reduction (TSS50) assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
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4 years
|
|
incidence and severity of adverse events and serious adverse events
기간: 4 years
|
incidence and severity of adverse events nd serious adverse events,as well as abnormal changes in clinical significance laboratory tests and other examinations
|
4 years
|
|
ORR:CR + PR + clinical improvement
기간: 4 years
|
Overall response rate (ORR, CR + PR + clinical improvement) as determined by the investigator according to IWG-MRT criteria
|
4 years
|
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LFS
기간: 4 years
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Leukemia-free survival (LFS) as assessed by the investigator
|
4 years
|
|
PFS
기간: 4 years
|
Progression free survival (PFS) as assessed by the investigator
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4 years
|
|
OS
기간: 4 years
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OS
|
4 years
|
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LDH
기간: 4 years
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Evaluation of changes in serum LDH levels
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4 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- JS110-002-I(T)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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