- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07802405
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.
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Shuai Guo
- Numero di telefono: 15902401702
- Email: sguo@wigenbio.com
Luoghi di studio
-
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Henan
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Zhengzhou, Henan, Cina, 450000
- Reclutamento
- Henan Cancer Hospital
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Contatto:
- Zhou Hu, PhD.
- Numero di telefono: 13939068863
- Email: papertigerhu@163.com
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Investigatore principale:
- Zhou Hu, Ph.D.
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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"
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: WJ01024 tablet
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5-20mg BID (dosage per investigator judgement)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
DLT
Lasso di tempo: 12 months
|
Incidence of DLT
|
12 months
|
|
AE
Lasso di tempo: 4 years
|
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
Lasso di tempo: 12 months
|
Evaluate the Maximum tolerated dose
|
12 months
|
|
RP2D
Lasso di tempo: 12 months
|
Evaluate the recommended dose for phase II
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pharmacokinetic (PK) Parameter
Lasso di tempo: 1.5 years
|
The blood concentration of WJ01024
|
1.5 years
|
|
SVR35
Lasso di tempo: 4 years
|
Percentage of subjects with spleen volume reduction of ≥35% (SVR35)
|
4 years
|
|
Score in MPN-SAF-TSS
Lasso di tempo: 4 years
|
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)
|
4 years
|
|
incidence and severity of adverse events and serious adverse events
Lasso di tempo: 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
Lasso di tempo: 4 years
|
Overall response rate (ORR, CR + PR + clinical improvement) as determined by the investigator according to IWG-MRT criteria
|
4 years
|
|
LFS
Lasso di tempo: 4 years
|
Leukemia-free survival (LFS) as assessed by the investigator
|
4 years
|
|
PFS
Lasso di tempo: 4 years
|
Progression free survival (PFS) as assessed by the investigator
|
4 years
|
|
OS
Lasso di tempo: 4 years
|
OS
|
4 years
|
|
LDH
Lasso di tempo: 4 years
|
Evaluation of changes in serum LDH levels
|
4 years
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- JS110-002-I(T)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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