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Tyrosine Kinase Inhibitor

NS-018 for Myelofibrosis

Phase 2

Recruiting

Research Sponsored by NS Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤2

Total Symptom Score (TSS) ≥10 on the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 24

Awards & highlights

Study Summary

This trialstudies people with a rare bone marrow disorder, Myelofibrosis, who have low platelet counts. Ages 18+ eligible.

Who is the study for?

This trial is for adults with Myelofibrosis, including those who developed it after Polycythemia Vera or Essential Thrombocythemia. Participants must have severe thrombocytopenia, a life expectancy over 6 months, and significant symptoms. They shouldn't have had recent surgery, other cancers within 2 years, uncontrolled infections or heart issues, or multiple JAK inhibitor treatments.Check my eligibility

What is being tested?

The study tests NS-018's effectiveness and safety against the Best Available Therapy (BAT) in treating Myelofibrosis with severe thrombocytopenia. It focuses on patients at intermediate-2 or high risk of disease progression according to DIPSS.See study design

What are the potential side effects?

Potential side effects of NS-018 are not specified here but may include typical reactions to cancer therapies such as fatigue, digestive issues, blood count changes and increased infection risk. BAT side effects vary depending on the chosen therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My symptom score is 10 or higher on the MFSAF.

Select...

My spleen is larger than normal, as confirmed by an MRI or CT scan.

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My condition is classified as intermediate-2 or high-risk myelofibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Total Symptom Score (TSS)

Secondary outcome measures

Change in spleen volume

Comparison of treatment-emergent AEs

Side effects data

From 2020 Phase 1 & 2 trial • 77 Patients • NCT01423851

40%

Fatigue

40%

Diarrhoea

33%

Dyspnoea

33%

Upper respiratory tract infection

33%

Cough

33%

Oedema peripheral

33%

Back pain

33%

Dizziness

27%

Headache

20%

Weight decreased

20%

Nausea

20%

Abdominal discomfort

20%

Arthralgia

20%

Pneumonia

20%

Abdominal pain

20%

Blood alkaline phosphatase increased

20%

Epistaxis

20%

Musculoskeletal pain

20%

Pruritus

20%

Anaemia

20%

Hyperuricaemia

20%

Fall

13%

Thrombocytopenia

13%

Decreased appetite

13%

Pyrexia

13%

Oedema

13%

Hypertension

13%

Muscle spasms

13%

Hyperhidrosis

13%

Pain in extremity

13%

Platelet count decreased

13%

Vomiting

13%

Gastrooesophageal reflux disease

13%

Dyspnoea exertional

13%

Early satiety

13%

Memory impairment

13%

Dizziness postural

13%

Somnolence

13%

Hyperglycaemia

13%

Dehydration

13%

Oral candidiasis

13%

Petechiae

13%

Contusion

13%

Nocturia

Muscle neoplasm

Wheezing

Dyspepsia

Joint effusion

Skin cancer

Abdominal distension

Lipase increased

Pulmonary oedema

Myalgia

Meibomian gland dysfunction

Pleural effusion

Heart rate abnormal

Neuralgia

Depression

Localised infection

Strabismus

Dry eye

Erectile dysfunction

Basal cell carcinoma

Cellulitis

Spinal stenosis

Glioblastoma multiforme

Hepatosplenomegaly

Constipation

Blood cholesterol increased

Rales

Asthenia

Chest pain

Bursitis

Musculoskeletal stiffness

Soft tissue mass

Paraesthesia

Hyperkalaemia

Infected seroma

Lip infection

Depressed mood

Emotional distress

Urinary tract pain

Photophobia

Angina pectoris

Myocardial infarction

Balance disorder

Hypoacusis

Hypocalcaemia

Animal scratch

Lumbar spinal stenosis

Insomnia

Influenza

Chills

Hyponatraemia

Transient ischaemic attack

Tremor

Sinusitis

Night sweats

Animal bite

Agitation

Claustrophobia

Palpitations

Glaucoma

Eye swelling

Ear pain

Confusional state

Suicide attempt

Sepsis

Splenomegaly

Enterocolitis

Acute coronary syndrome

Coronary artery occlusion

Anal sphincter atony

Dysphagia

Flatulence

Weight increased

White blood cell count decreased

Blood potassium increased

Serum ferritin increased

Troponin I increased

Wound infection

Nasal congestion

Bronchospasm

Dysphonia

Ecchymosis

Pleuritic pain

Sleep apnoea syndrome

Chest discomfort

Non-cardiac chest pain

Fibromyalgia

Osteoarthritis

Synovial cyst

Neuropathy peripheral

Ataxia

Lethargy

Sensory disturbance

Increased tendency to bruise

Hyperphosphataemia

Nasopharyngitis

Bronchitis

Skin infection

Rash maculo-papular

Rash

Erythema

Neurodermatitis

Muscle strain

Skin wound

Dysuria

Haematuria

Sinus bradycardia

Hot flush

Blepharitis

Eyelid irritation

Lacrimation increased

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: 300 mg QD

Part 1: 250 mg BID

Part 1: 400 mg BID

Part 2: 300 mg QD

Part 1: 75 mg QD

Part 1: 125 mg QD

Part 1: 200 mg QD

Part 1: 400 mg QD

Part 1: 100 mg BID

Part 1: 200 mg BID

Part 1: 300 mg BID

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NS-018Experimental Treatment1 Intervention

Self-administered NS-018 300 mg orally, twice daily, preferably at the same time each day in consecutive 4-week (28-day) cycles

Group II: Best Available Therapy (BAT)Active Control1 Intervention

Single agent per Investigator discretion or no therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NS-018

2011

Completed Phase 2

~80

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nippon Shinyaku Co., Ltd.Industry Sponsor

12 Previous Clinical Trials

481 Total Patients Enrolled

NS Pharma, Inc.Lead Sponsor

13 Previous Clinical Trials

454 Total Patients Enrolled

1 Trials studying Primary Myelofibrosis

77 Patients Enrolled for Primary Myelofibrosis

Media Library

NS-018 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04854096 — Phase 2

Primary Myelofibrosis Research Study Groups: NS-018, Best Available Therapy (BAT)

Primary Myelofibrosis Clinical Trial 2023: NS-018 Highlights & Side Effects. Trial Name: NCT04854096 — Phase 2

NS-018 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04854096 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed into this experiment?

"Affirmative. Details on clinicaltrials.gov verify that the trial, inaugurated on December 1st 2022, is currently seeking participants. Consequently, 120 patients must be enrolled from two distinct medical centres."

Answered by AI

Has NS-018 been given the greenlight by the FDA?

"Due to the lack of evidence on NS-018's efficacy, but positive data surrounding safety protocols, our team at Power assessed its risk profile as a 2."

Answered by AI

Is this medical research recruiting participants at the present moment?

"Affirmative, according to the clinicaltrials.gov database this medical experiment is currently recruiting volunteers. It was inaugurated on December 1st 2022 and recently edited on October 31st 2022; 120 patients must be recruited from 2 distinct facilities."

Answered by AI

Is this exploration the inaugural of its class?

"At this moment, only one trial for NS-018 is being conducted in 3 cities and 4 countries. Nippon Shinyaku Co., Ltd. sponsored the inaugural clinical study of this drug back in 2022 with 120 participants which concluded its Phase 2 approval stage. Since then, 7 experiments have been finalized."

Answered by AI

Have there been any preceding investigations involving NS-018?

"Currently, there is only one clinical trial exploring the effects of NS-018. This study has not yet advanced to Phase 3 and 17 different locations across Kuala Lumpur and Texas are running trials for it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04854096.

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