A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients (MOMENTUM)
Study Purpose
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic subjects who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, UK, and US. Subjects must be symptomatic with a MFSAF v4.0 Total Symptom Score of ≥ 10 at screening, and be anemic with Hgb < 10 g/dL. For subjects with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Subjects will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Subjects randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the subject tolerates and continues to benefit from MMB. Subjects randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances:
- - at the end of Week 24 if they complete the randomized treatment period; or.
- - at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or.
- - at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically-confirmed symptomatic splenic progression.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
1. Age ≥ 18 years. 2. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria). 3. Symptomatic, defined as a TSS of ≥ 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Day BL1. 4. Anemic, defined as a Hgb < 10 g/dL in Screening/Baseline period. 5. Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for ≥ 90 days, or ≥ 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of ≥ 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma. 6. Baseline splenomegaly, defined as having a palpable spleen at ≥ 5 cm, below the left costal margin, or with volume ≥ 450 cm³ on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization. 7. High risk, intermediate-2, or intermediate-1 risk MF as defined by DIPSS, or DIPSS-plus. 8. No allogeneic stem cell transplant planned. 9. Acceptable laboratory assessments:- - Absolute neutrophil count (ANC) ≥ 0.75 × 10⁹/L.
- - Platelet count (PLT) ≥ 25 × 10⁹/L (without requirement for platelet transfusion).
- - Peripheral blast count < 10%.
- - Alanine aminotransferase/ glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 3 × ULN (≤ 5 × ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days).
- - Calculated creatinine clearance (CCr) ≥ 30 mL/min according to Cockcroft-Gault.
- - Direct bilirubin ≤ 2.0 × ULN.
Exclusion Criteria:
1. Use of the following treatments within the time periods noted: 1. Prior momelotinib treatment at any time. 2. Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 week prior to the first day of Baseline. 3. Active anti-MF therapy within 1 week prior to the first day of Baseline. 4. Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization. 5. Investigational agent (including investigational JAK inhibitors) within 4 weeks prior to Randomization. 6. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization. 7. Danazol within 3 months prior to Randomization. 8. Splenic irradiation within 3 months prior to Randomization. 9. Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin. 2. History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured. 3. Prostate specific antigen (PSA) > 4 ng/mL. 4. Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI or CT scan for spleen volume measurement per protocol requirements. 5. Any of the following (criteria a- - k): 1.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04173494 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sierra Oncology, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Srdan Verstovsek, M.D., Ph.D. |
Principal Investigator Affiliation | Department of Leukemia, The University of Texas MD Anderson Cancer Center |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Korea, Republic of, New Zealand, Poland, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis |
Arms
Experimental: Momelotinib
Participants will receive momelotinib plus placebo to match danazol
Active Comparator: Danazol
Participants will receive danazol plus placebo to match momelotinib
Interventions
Drug: - Momelotinib
Momelotinib tablets will be self-administered orally once daily
Drug: - Danazol
Danazol capsules will be self-administered orally twice daily
Drug: - Placebo to match momelotinib
Momelotinib placebo tablets will be self-administered orally once daily
Drug: - Placebo to match danazol
Danazol placebo capsules will be self-administered orally twice daily
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Mayo Clinic Hospital - Phoenix
Phoenix, Arizona, 85054
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Irvine Center for Clinical Research
Irvine, California, 92614
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Norris Comprehensive Cancer Center
Los Angeles, California, 91011
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American Institute of Research - Whittier
Whittier, California, 90603
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University of Colorado Hospital Anschutz Cancer Pavilion
Aurora, Colorado, 80045
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Georgetown University Medical Center
Washington, District of Columbia, 20057
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Moffitt Cancer Center
Tampa, Florida, 33612
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Northwest Oncology & Hematology - Rolling Meadows
Rolling Meadows, Illinois, 60008
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Washington University School of Medicine in Saint Louis
Saint Louis, Missouri, 63110
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Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Columbia University Irving Medical Center - Presbyterian Hospital
New York, New York, 10032
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Cleveland Clinic - Richard E. Jacobs Health Center
Avon, Ohio, 44011
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Gabrail Cancer Center
Canton, Ohio, 44718
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
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Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
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The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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International Sites
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Canberra Region Cancer Centre
Garran, Australian Capital Territory, 2605
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Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
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Flinders Medical Centre
Bedford Park, South Australia, 5042
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The Alfred Hospital
Melbourne, Victoria, 3004
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Perth Radiological Clinic - Magnetic Resonance Centre
Perth, Western Australia, 6000
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Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020
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Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, 4020
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Medizinische Universität Wien
Wien, Vienna, 1090
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Oberösterreichische Gesundheitsholding GmbH
Steyr, , 4400
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Hôpital Erasme
Bruxelles, Brussels, 1070
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Grand Hôpital de Charleroi - Notre Dame
Charleroi, Hainaut, 6000
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Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Brugge, West-Vlaanderen, 8000
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Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerpen, , 2060
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Centre Hospitalier Universitaire de Liège
Liège, , B-4000
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University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, , 5800
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University Hospital St. Ivan Rilski
Sofia, , 1431
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University Multiprofile Hospital For Active Treatment Aleksandrovska
Sofia, , 1431
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National Specialized Hospital for Active Treatment of Haematologic Diseases
Sofia, , 1756
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Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
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Queen Elizabeth II Health Sciences Centre - Halifax Infirmary
Halifax, Nova Scotia, B3H 1V7
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McMaster University Medical Center
Hamilton, Ontario, L8V 5C2
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
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Research Institute of the McGill University Health Centre
Montréal, Quebec, H3H 2R9
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Hôpital de l'Enfant-Jésus
Québec, , G1J 1Z4
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Fakultni Nemocnice Brno
Brno, Jihormoravsky Kraj, 625 00
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Herlev Hospital
Herlev, Hovedstaden, 2730
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Aalborg Universitetshospital - Syd
Aalborg, Nordjylland, 9000
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Sjællands Universitetshospital - Roskilde
Roskilde, Sjælland, 4000
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Odense Universitetshospital
Odense, Syddanmark, 5000
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Hôpital Haut-Lévêque
Pessac, Aquitaine, 33604
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Hospital Center University Of Caen Normandie
Caen, Basse-Normandie, 14033
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Hôpital Claude Huriez
Lille, Hauts-de-France, 59037
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Hôpital Saint-Louis
Paris, Ile-de-France, 75010
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Hôpital Saint-Antoine
Paris, Ile-de-France, 75571
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Centre Hospitalier Universitaire Limoges
Limoges, Limousin, 87042
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Centre Hospitalier De Lens
Lens, Nord Pas-Des-Calais, 62307
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Centre Hospitalier Le Mans
Le Mans, Pays De La Loire, 72037
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Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
Amiens, Picardie, 80054
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Hôpital l'Archet
Nice, Provence-Alpes-Côte d'Azur, 06200
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Centre Hospitalier Lyon-Sud
Pierre-Bénite, Rhone-Alps, 69495
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Centre Hosptitalier Universitaire Angers
Angers, , 49 933
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Hôpital Saint-Vincent De Paul - Lille
Lille, , 59000
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Hôpital De La Conception
Marseille, , 13385
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Hôpital Emile Muller
Mulhouse, , 68100
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Centre Hospitalier Universitaire Nantes - Hôtel Dieu
Nantes, , 44000
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Centre Hospitalier Universitaire de Poitiers
Poitiers, , 86021
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Universitätsklinikum Aachen
Aachen, Nordrhein-Westfalen, 52074
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Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, 45147
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Johannes Wesling Klinikum Minden
Minden, Nordrhein-Westfalen, 32429
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Universitätsklinikum Halle
Halle, Sachsen-Anhalt, 06120
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Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Sachsen, 01307
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Universitätsklinikum Leipzig
Leipzig, Sachsen, 04103
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Universitätsklinikum Jena
Jena, Thuringen, 07747
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Uniklinik Köln
Köln, , 50937
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Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , 23538
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Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
Mutlangen, , 73557
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Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, 7624
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Debreceni Egyetem Klinikai Központ
Debrecen, Hajdu-Bihar, 4032
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Szent Borbála Kórház
Tatabánya, Komárom-Esztergom, 2800
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Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely
Budapest, Pest, 1097
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Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy, 7400
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Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
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Markusovszky Egyetemi Oktatókórház Szombathely
Szombathely, Vas, 9700
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Semmelweis Egyetem
Budapest, , 1083
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Petz Aladár Megyei Oktató Kórház
Győr, , 9023
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Yitzhak Shamir Medical Center
Be'er Ya'aqov, Central District, 7030000
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Bnai Zion Medical Center
Haifa, Haifa District, 31048
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Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem District,
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Rambam Health Care Campus
Haifa, , 3109601
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Carmel Medical Center
Haifa, , 3436212
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Shaare Zedek Medical Center
Jerusalem, , 9103102
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Meir Medical Center
Kfar Saba, , 4428164
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Western Galilee Hospital-Nahariya
Nahariya, ,
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Rabin Medical Center - Beilinson Hospital
Petah tikva, , 4941492
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Tel Aviv Sourasky Medical Center
Tel Aviv, ,
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Azienda Ospedaliero - Universitaria Careggi
Firenze, Florence, 50134
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Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, 47014
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Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
Monza, Monza E Brianza, 20900
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Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Pesaro E Urbino, 61121
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IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero In Vulture, Potenza, 85028
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Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, 10126
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Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Turin, 10128
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Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria
Alessandria, , 15121
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Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
Bologna, , 40138
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Ospedale Policlinico San Martino
Genova, , 16132
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, , 20122
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Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano, , 20162
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Azienda Ospedaliera Universitaria Federico II
Napoli, , 80131
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Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, , 28100
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Umberto I - Policlinico di Roma
Roma, , 00161
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Fondazione Policlinico Universitario Agostino Gemelli
Roma, , 20123
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Presidio Ospedaliero Universitario Santa Maria della Misericordia
Udine, , 33100
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Ospedale di Circolo e Fondazione Macchi
Varese, , 21100
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Ospedale Policlinico Giambattista Rossi Borgo Roma
Verona, , 37134
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Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, 41944
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Inje University Busan Paik Hospital
Busan, , 47392
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Inje University Haeundae Paik Hospital
Busan, , 48108
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Seoul National University Bundang Hospital
Seongnam-si, , 13620
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Severance Hospital
Seoul, , 03722
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The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul, , 06591
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Samsung Medical Center
Seoul, ,
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Seoul National University Hospital
Seoul, ,
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Ulsan University Hospital
Ulsan, , 44033
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North Shore Hospital
Auckland, , 0622
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Middlemore Clinical Trials
Auckland, , 2025
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Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku
Wrocław, Dolnoslaskie, 50-367
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Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lubelskie, 20-081
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Szpital Uniwersytecki w Krakowie
Kraków, Malopolskie, 31-501
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Instytut Hematologii I Transfuzjologii
Warszawa, Mazowieckie, 02-776
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Alvamed Zakład Specjalistycznej Opieki Zdrowotnej
Warszawa, Mazowieckie, 03-401
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Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Kraków, Małopolskie, 31-826
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Szpital Wojewódzki w Opolu
Opole, Opolskie, 45-064
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Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdańsk, Pomorskie, 80-214
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Silesian Healthy Blood Clinic
Chorzów, Salskie, 41-503
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Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź, , 93-513
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Spitalul Filantropia - Craiova
Craiova, Dolj, 200143
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Institutul Regional De Oncologie Iasi
Iaşi, Iasi County, 700483
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Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu-Mureş, Mureș, 540136
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Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov
Braşov, , 500366
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Coltea - Spital Clinic
Bucharest, , 030 171
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Singapore General Hospital
Singapore, , 169608
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Tan Tock Seng Hospital
Singapore, , 308433
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Hospital Universitario Central de Asturias
Oviedo, Asturias, 33011
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Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, , 08003
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Hospital Universitari Vall d'Hebrón
Barcelona, , 08035
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Hospital Germans Trias i Pujol
Barcelona, , 08916
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Hospital San Pedro de Alcantara
Cáceres, , 10003
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Institut Català d'Oncologia Girona
Girona, , 17007
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Hospital Universitario Ramón y Cajal
Madrid, , 28034
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Hospital Universitario 12 de Octubre
Madrid, , 28041
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Hospital Universitario Virgen de la Victoria
Málaga, , 29010
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Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, , 37007
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Hospital Universitario Virgen del Rocío
Sevilla, , 41013
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Hospital Universitario La Fe
Valencia, , 46009
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Hospital de Día Quirónsalud Zaragoza
Zaragoza, , 50012
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Status
Recruiting
Address
Karolinska Universitetssjukhuset Solna
Solna, Stockholm, 171 76
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Status
Recruiting
Address
Sahlgrenska Universitetssjukhuset
Göteborg, Västra Götalands Län, 413 45
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Status
Recruiting
Address
Uddevalla Sjukhus
Uddevalla, , 45153
Site Contact
Status
Recruiting
Address
Chiayi Chang Gung Memorial Hospital
Puzi City, Chaiyi, 613
Site Contact
Status
Recruiting
Address
China Medical University Hospital
Taichung City, Taichung, 40447
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Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
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Status
Recruiting
Address
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, , 333
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Status
Recruiting
Address
United Lincolnshire Hospitals NHS Trust
Boston, England, PE21 9QS
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Status
Recruiting
Address
University Hospitals Bristol NHS Foundation Trust
Bristol, England, BS2 8ED
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Status
Recruiting
Address
University College London Hospitals NHS Foundation Trust
London, England, NW1 2PG
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Status
Recruiting
Address
Guy's and Saint Thomas' NHS Foundation Trust
London, England, SE1 9RT
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Status
Recruiting
Address
Imperial College Healthcare NHS Trust
London, England, W12 0HS
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Status
Recruiting
Address
University Hospital Southampton NHS Foundation Trust
Southampton, England, SO16 6YD
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Status
Recruiting
Address
NHS Lanarkshire
Airdrie, Scotland, ML6 0JS
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