- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Shuai Guo
- Telefoonnummer: 15902401702
- E-mail: sguo@wigenbio.com
Studie Locaties
-
-
Henan
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Zhengzhou, Henan, China, 450000
- Werving
- Henan Cancer Hospital
-
Contact:
- Zhou Hu, PhD.
- Telefoonnummer: 13939068863
- E-mail: papertigerhu@163.com
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Hoofdonderzoeker:
- Zhou Hu, Ph.D.
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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"
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: WJ01024 tablet
|
5-20mg BID (dosage per investigator judgement)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
DLT
Tijdsspanne: 12 months
|
Incidence of DLT
|
12 months
|
|
AE
Tijdsspanne: 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
Tijdsspanne: 12 months
|
Evaluate the Maximum tolerated dose
|
12 months
|
|
RP2D
Tijdsspanne: 12 months
|
Evaluate the recommended dose for phase II
|
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pharmacokinetic (PK) Parameter
Tijdsspanne: 1.5 years
|
The blood concentration of WJ01024
|
1.5 years
|
|
SVR35
Tijdsspanne: 4 years
|
Percentage of subjects with spleen volume reduction of ≥35% (SVR35)
|
4 years
|
|
Score in MPN-SAF-TSS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 4 years
|
Overall response rate (ORR, CR + PR + clinical improvement) as determined by the investigator according to IWG-MRT criteria
|
4 years
|
|
LFS
Tijdsspanne: 4 years
|
Leukemia-free survival (LFS) as assessed by the investigator
|
4 years
|
|
PFS
Tijdsspanne: 4 years
|
Progression free survival (PFS) as assessed by the investigator
|
4 years
|
|
OS
Tijdsspanne: 4 years
|
OS
|
4 years
|
|
LDH
Tijdsspanne: 4 years
|
Evaluation of changes in serum LDH levels
|
4 years
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- JS110-002-I(T)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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