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Janus Kinase Inhibitor
Momelotinib for Myelofibrosis
Phase 3
Waitlist Available
Led By Srdan Verstovsek, M.D., Ph.D.
Research Sponsored by Sierra Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 24 to a maximum of 151 weeks
Awards & highlights
Study Summary
This trial is comparing the effectiveness and safety of MMB to DAN in treating and reducing symptoms, the need for blood transfusions and splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF.
Eligible Conditions
- Myelofibrosis
- Primary Myelofibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 24 to a maximum of 151 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 24 to a maximum of 151 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Symptom Score (TSS) Response Rate at Week 24
Secondary outcome measures
Change From Baseline in Cancer-related Fatigue as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at Week 24
Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24
Change From Baseline in MFSAF TSS at Week 24
+17 moreSide effects data
From 2019 Phase 3 trial • 156 Patients • NCT0210126832%
Diarrhoea
19%
Asthenia
19%
Nausea
17%
Cough
17%
Thrombocytopenia
15%
Fatigue
15%
Abdominal pain
15%
Dizziness
15%
Headache
14%
Anaemia
13%
Pyrexia
13%
Pruritus
12%
Dyspnoea
11%
Oedema peripheral
11%
Urinary tract infection
11%
Constipation
10%
Arthralgia
10%
Hypertension
10%
Dyspepsia
10%
Weight decreased
9%
Upper respiratory tract infection
8%
Abdominal pain upper
8%
Paraesthesia
8%
Night sweats
8%
Hyperkalaemia
8%
Epistaxis
7%
Vomiting
7%
Oral herpes
7%
Decreased appetite
7%
Vitamin B1 deficiency
7%
Neutropenia
7%
Peripheral sensory neuropathy
6%
Hyperuricaemia
6%
Blood creatinine increased
5%
Hyperhidrosis
5%
Back pain
5%
Bronchitis
5%
Pain in extremity
5%
Contusion
4%
Hyponatraemia
4%
Nasopharyngitis
4%
Hypocalcaemia
4%
Hypokalaemia
4%
Abdominal discomfort
4%
Ascites
3%
Insomnia
3%
Cardiac failure
3%
Muscle spasms
3%
Hypotension
3%
Early satiety
2%
Dry skin
2%
Splenomegaly
2%
Oral candidiasis
2%
Respiratory failure
2%
General physical health deterioration
2%
Cellulitis
2%
Pneumonia
2%
Sepsis
2%
Supraventricular tachycardia
2%
Gastrointestinal haemorrhage
2%
Upper gastrointestinal haemorrhage
2%
Acute kidney injury
2%
Presyncope
2%
Bone pain
2%
Fall
2%
Chills
2%
Dry mouth
2%
Somnolence
1%
Dysuria
1%
Melaena
1%
Bacterial sepsis
1%
Ophthalmic herpes zoster
1%
Abdominal distension
1%
Hypophosphataemia
1%
Postmenopausal haemorrhage
1%
Spontaneous haematoma
1%
Tumour lysis syndrome
1%
Cardiac failure congestive
1%
Generalised oedema
1%
Acute respiratory distress syndrome
1%
Groin pain
1%
Hypersensitivity
1%
Cardiac arrest
1%
Diverticulitis
1%
Enterobacter bacteraemia
1%
Lung infection
1%
Peritonitis bacterial
1%
Sinusitis
1%
Restless legs syndrome
1%
Angina unstable
1%
Atrial fibrillation
1%
Gastric ulcer
1%
Gastrointestinal angiodysplasia
1%
Haematemesis
1%
Nephrolithiasis
1%
Renal failure
1%
Pleural effusion
1%
Femur fracture
1%
Subdural haematoma
1%
Malignant melanoma
1%
Aortic stenosis
1%
Leukocytosis
1%
Alopecia
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Momelotinib (MMB)
Best Available Therapy (BAT)
MMB to MMB
BAT to MMB
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MomelotinibExperimental Treatment2 Interventions
Participants will receive momelotinib plus placebo to match danazol
Group II: DanazolActive Control2 Interventions
Participants will receive danazol plus placebo to match momelotinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Momelotinib
2013
Completed Phase 3
~1060
Placebo to match danazol
2020
Completed Phase 3
~200
Find a Location
Who is running the clinical trial?
Sierra Oncology, Inc.Lead Sponsor
19 Previous Clinical Trials
1,757 Total Patients Enrolled
Sierra Oncology LLC - a GSK companyLead Sponsor
19 Previous Clinical Trials
1,757 Total Patients Enrolled
Srdan Verstovsek, M.D., Ph.D.Principal InvestigatorDepartment of Leukemia, The University of Texas MD Anderson Cancer Center
1 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are classified as having high-risk, intermediate-2 or intermediate-1 myelofibrosis according to DIPSS criteria, or the more stringent DIPSS-plus.You have had or currently have another type of cancer that could affect the safety or effectiveness of the experimental treatment being studied.You still have side effects from previous treatments that are not fully resolved and are considered moderate or severe.You have taken JAK inhibitor medication (like fedratinib or ruxolitinib) within one week before the study starts.You are anemic, as evidenced by a Hemoglobin level lower than 10 g/dL during the Screening/Baseline period.You have a history of a condition called porphyria.You have received radiation treatment to your spleen within the last 3 months.You must be at least 18 years of age.You experience symptoms as assessed by the MFSAF v4.0 measurement prior to Day BL1, with scores of 10 or above.You are not scheduled to receive a stem cell transplant from a donor.You have recently received certain treatments, and there are specific time limits before you can participate in this study.Your heart rhythm has not been stable within the past 6 months.You cannot have taken any experimental medications, including JAK inhibitors, within 4 weeks before the study starts.You have experienced chest pain that is unstable and has occurred within the last 6 months.You have experienced heart failure symptoms in the past 6 months.You have taken momelotinib before, at any time.I'm sorry, but I need the specific criteria (a - k) in order to provide simplified explanations for each of them.You have been diagnosed with PMF or Post-PV/ET MF as per WHO 2016 guidelines, or IWG-MRT criteria.Your absolute neutrophil count is at least 0.75 × 10E9/L.You have previously been treated with a verified JAK inhibitor for Polycythemia Vera or Essential Thrombocytosis for at least 90 days, or 28 days if the treatment has caused you to require 4 or more red blood cell transfusions within 8 weeks, or is associated with Grade 3/4 side effects such as thrombocytopenia, anemia, and hematoma.You must have a spleen that is either palpable ≥ 5 cm below the left costal margin or has a volume of ≥ 450 cm³ on imaging (ultrasound, MRI or CT) as determined during Screening before Randomization.
Research Study Groups:
This trial has the following groups:- Group 1: Momelotinib
- Group 2: Danazol
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators still enrolling new patients in this research study?
"Unfortunately, this particular trial is not currently seeking patients. It was first made public on February 7th, 2020 and had its last update on January 27th, 2022. With that being said, there are 126 other trials for primary myelofibrosis and 10 for Momelotinib that are looking for participants."
Answered by AI
Which medical condition is Momelotinib mostly used as a therapy for?
"Momelotinib has shown efficacy in treating patients with breast cancer, angioedemas, hereditary conditions, and thrombocytopenia."
Answered by AI
What is the clinical data for Momelotinib's efficacy?
"Momelotinib was first studied in 2017 at Eastern Regional Health Authority. Since the initial study, there have been 18 completed clinical trials. At the moment, there are 10 active studies, many of which are based in Toronto, Ontario."
Answered by AI
What makes this clinical test innovative?
"Since 2017, there has been an uptick in research surrounding Momelotinib. The first clinical trial was sponsored by PSI CRO in 2017 and only involved 399 patients. Despite this, the drug received Phase 3 approval for general use. Presently, there are 10 active trials being conducted in 29 different countries and 152 cities."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
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