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JOURNAL ONKOLOGIE – STUDIE

Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis

Rekrutierend

NCT-Nummer:
NCT04854096

Studienbeginn:
Januar 2023

Letztes Update:
18.04.2024

Wirkstoff:
NS-018, Best Available Therapy

Indikation (Clinical Trials):
Polycythemia Vera, Primary Myelofibrosis, Polycythemia, Thrombocytosis, Thrombocythemia, Essential

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
NS Pharma, Inc.

Collaborator:
Nippon Shinyaku Co., Ltd.

Kontakt

Studienlocations
(3 von 52)

Hamatologisch-onkologische Praxis Heinric/Bangerter Ausgsburg GbR
86150 Augsburg
(Bayern)
GermanyZurückgezogen» Google-Maps
Universitaetsklinikum Halle (Saale)
6120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Jena
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Pankreaskarzinomzentrum der Universitätsmedizin Rostock
Doberaner Straße 137-139
18057 Rostock
DeutschlandRekrutierend» Google-Maps
University of Massachusetts Chan Medical School
01655 Worcester
United StatesRekrutierend» Google-Maps
Houston Methodist Hospital
77002 Houston
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Azienda Ospedaliera SS. Antonio
15121 Alessandria
ItalyNoch nicht rekrutierend» Google-Maps
ASST Spedali Civili di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
AOU "Policlinico - San Marco"
95123 Catania
ItalyNoch nicht rekrutierend» Google-Maps
ASST Fatebenefratelli Sacco
20121 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
20122 Milano
ItalyNoch nicht rekrutierend» Google-Maps
AO di Rilievo Ntl A Cardarelli
80131 Naples
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera di Rilievo Nazionale
80131 Naples
ItalyZurückgezogen» Google-Maps
Azienda Ospedaliera di Padova
35128 Padova
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
90127 Palermo
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori Regina Elena IRCCS
00144 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Policlinico Umberto I
00161 Roma
ItalyNoch nicht rekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital
164 KR Banpo-dong
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Gyeongsang National University Hospital
52727 Jinju-si
Korea, Republic ofRekrutierend» Google-Maps
CHA Bundang Medical Center, CHA University
164 KR Seongnam
Korea, Republic ofZurückgezogen» Google-Maps
Soon Chun Hyang Central Medical Center
4401 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Hospital Raja Permaisuri Bainun
30450 Ipoh
MalaysiaZurückgezogen» Google-Maps
Hospital Sultanah Aminah
80100 Johor Bahru
MalaysiaRekrutierend» Google-Maps
Hospital Raja Perempuan Zainab II
15586 Kota Bahru
MalaysiaRekrutierend» Google-Maps
Hospital Queen Elizabeth
88586 Kota Kinabalu
MalaysiaRekrutierend» Google-Maps
University Malaya Medical Centre
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Szpital Uniwersytecki nr 2 im. dr J. Biziela
85-168 Bydgoszcz
PolandNoch nicht rekrutierend» Google-Maps
Dolnośląskie Centrum Onkologii we Wrocławiu, Oddział Hematologiczny
53-413 , Wrocław
PolandNoch nicht rekrutierend» Google-Maps
Istanbul Medipol University
34200 Bagcilar
TurkeyNoch nicht rekrutierend» Google-Maps
Ege Universitesi Tip Fak,
İzmir
TurkeyNoch nicht rekrutierend» Google-Maps
Namik Kemal University Medicine School
59100 Tekirdağ
TurkeyNoch nicht rekrutierend» Google-Maps
Karadeniz Teknik Universitesi Tip Fak,
61100 Trabzon
TurkeyNoch nicht rekrutierend» Google-Maps
Royal United Hospitals - Bath
BA1 3NG Bath
United KingdomRekrutierend» Google-Maps
Guys Hospital
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
University College London Hospitals
WC1E 6HX London
United KingdomNoch nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
Derriford Hospital
PL6 8DH Plymouth
United KingdomRekrutierend» Google-Maps
Sandwell & West Birmingham Hospital
B71 4HJ West Bromwich
United KingdomRekrutierend» Google-Maps
Western General Hospital
EH2XU 4 Edinburgh
United KingdomNoch nicht rekrutierend» Google-Maps
Western General Hospital
EH4 2XU Edinburgh
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

NS-018 will be self-administered orally at a dose of 300 mg BID. The BAT will be administered

according to manufacturer's instructions and Investigator discretion. Subjects will complete

study visits at Screening, Day 1 and Day 15 of Cycle 1, 2, 3, 4, 5, 6 and Day 1 of every

cycle thereafter. At these visits, blood/urine sampling, spleen measurements, bone marrow

assessments, patient-reported outcome (PRO) assessments, and safety assessments may be

performed.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Primary MF, post-PVMF or post-ETMF according to the DIPSS risk categories of

intermediate-2 or high-risk MF

- Average platelet count of <50,000/µL at Screening based on 2 measurements taken on

different days; both measurements must be <50,000/µL.

- ECOG performance status ≤2.

- Life expectancy >6 months.

- Spleen volume of at least 450 cm3 measured by MRI (or by CT for applicable subjects).

- Total Symptom Score (TSS) ≥10 on the Myelofibrosis Symptom Assessment Form (MFSAF)

version 4.0.

- Peripheral blast count <10%.

- No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including

JAK inhibitor, erythropoietic, thrombopoietic agent, or any use of corticosteroids for

MF symptom or blood count management. Low dose corticosteroids <10 mg/day prednisone

or equivalent is allowed for non-MF purposes.

Exclusion Criteria:

- Active, uncontrolled systemic infection.

- Any prior treatment with more than two JAK inhibitors.

- Previous treatment with NS-018.

- Subjects actively receiving a concurrent investigational agent.

- Subjects with any unresolved AE greater than Grade 1 other than hematological AEs from

previous anticancer therapy.

- Currently taking medication that is substantially metabolized by cytochrome P450 (CYP)

1A2 or CYP3A4 (see Appendix 5) or taking medication known to be strong inhibitors or

inducers of CYP3A4 (see Appendix 5).

- Radiation therapy for splenomegaly within 6 months prior to study entry (screening).

- History of splenectomy or planning to undergo splenectomy.

- Subjects with a serious cardiac condition within the past 6 months such as

uncontrolled arrhythmias, myocardial infarction, angina or heart disease

- Subjects diagnosed with another malignancy within 2 years prior to an enrollment.

- Subjects who have had surgery (other than placement of vascular access and bone marrow

biopsy) within 4 weeks of study entry (screening), or subjects with incomplete

recovery from any prior surgical procedures.

Studien-Rationale

Primary outcome:

1. Change in spleen volume (Time Frame - from baseline to week 24):
Proportion of subjects who achieve ≥35% change in spleen volume from baseline to Week 24 as measured by MRI (or by CT for applicable subjects)

2. Change in Total Symptom Score (TSS) (Time Frame - from baseline to week 24):
Proportion of subjects who achieve ≥50% change in total symptom score from baseline to Week 24 as measured by the MFSAF v4.0

Secondary outcome:

1. Change in spleen volume (Time Frame - from baseline at anytime up to week 24):
Proportion of subjects in NS-018 vs BAT arm who achieve ≥35% change in spleen volume from baseline at any time up to Week 24 as measured by MRI (or by CT for applicable subjects)

2. Comparison of treatment-emergent AEs (Time Frame - from baseline to week 24):
Laboratory events graded by the NCI CTCAE v5.0 will be assessed in both arms, NS-018 vs BAT.

Studien-Arme

  • Experimental: NS-018
    Self-administered NS-018 300 mg orally, twice daily, preferably at the same time each day in consecutive 4-week (28-day) cycles
  • Active Comparator: Best Available Therapy (BAT)
    Single agent per Investigator discretion or no therapy

Geprüfte Regime

  • NS-018:
    Experimental
  • Best Available Therapy:
    Active Comparator

Quelle: ClinicalTrials.gov


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