Extended Access of Momelotinib in Adults With Myelofibrosis

Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Sponsors

Lead Sponsor: Sierra Oncology, Inc.

Source Sierra Oncology, Inc.
Brief Summary

The primary objective of this study is to provide extended access of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease.

Overall Status Enrolling by invitation
Start Date 2018-05-03
Completion Date 2024-12-01
Primary Completion Date 2024-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants Who Had Access to, and Received the Intervention Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.
Enrollment 400
Condition
Intervention

Intervention Type: Drug

Intervention Name: MMB

Description: Tablet(s) administered orally once daily

Eligibility

Criteria:

Key Inclusion Criteria: - Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301 - Able to comprehend and willing to sign the informed consent form Key Exclusion Criteria: - Known hypersensitivity to MMB, its metabolites, or formulation excipients NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Sierra Oncology, Inc. Study Director Sierra Oncology, Inc.
Location
Facility:
IC Irvine Health | Orange, California, 92868, United States
Stanford Hospital and Clinics | Stanford, California, 94305, United States
Mayo Clinic Florida | Jacksonville, Florida, 32224, United States
Winship Cancer Institute, Emory University | Atlanta, Georgia, 30322, United States
Saint Agnes Hospital | Baltimore, Maryland, 21229, United States
Dana-Farber Cancer Institute (DFCI) | Boston, Massachusetts, 02215, United States
Mayo Clinic - Department of Hematology | Rochester, Minnesota, 55905, United States
Washington University School of Medicine Siteman Cancer Center | Saint Louis, Missouri, 63110, United States
Montefiore Medical Center | Bronx, New York, 10467, United States
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States
Mayo Clinic Building - Phoenix | Milwaukee, Wisconsin, 53226, United States
Icon Cancer Care Wesley | Hyde Park, Queensland, 4812, Australia
Frankston Hospital | Frankston, Victoria, 3199, Australia
The Alfred Hospital | Melbourne, Victoria, 3004, Australia
Peter MacCallum Cancer Centre | Parkville, Victoria, 3050, Australia
Royal Perth Hospital | Perth, Western Australia, 6160, Australia
Ziekenhuis Netwerk Antwerpen Stuivenberg | Antwerp, 2060, Belgium
Universitaire Ziekenhuis Leuven | Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège Site Sart Tilman | Liège, 4000, Belgium
UMHAT Dr. Georgi Stranski EAD | Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment Ruse | Ruse, 7002, Bulgaria
National Specialized Hospital for Active Treatment of Haematologic Diseases | Sofia, 1431, Bulgaria
Sir Mortimer B. Davis Jewish General Hospital | Montréal, H3T 1E2, Canada
Princess Margaret Cancer Centre | Toronto, M5G 2M9, Canada
Aalborg University Hospital | Aalborg, 9000, Denmark
Gentofte Hospital | Herlev, 2730, Denmark
Hopital Saint-Louis | Paris, ILE-De-FRANCE, 75475, France
CHRU Huriez Lille | Lille Cedex, 59020, France
Institut Paoli Calmettes | Marseille, 13273, France
Hôpital Haut-Lévêque | Pessac Cedex, 33604, France
Centre Hospitalier Lyon Sud | Pierre Bénite Cedex, 69495, France
Institut Universitaire du Cancer | Toulouse Cedex 9, 31059, France
Universitätsklinikum Halle | Halle, Sachsen-Anhalt, 06120, Germany
University Hospital of Cologne | Cologne, 50937, Germany
Universitätsklinikum Dresden | Dresden, 01307, Germany
Universitätsklinikum Leipzig | Leipzig, 04103, Germany
Johannes Gutenberg-Universität Mainz | Mainz, 55131, Germany
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház | Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia | Budapest, 1083, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek | Debrecen, 4032, Hungary
Somogy Megyei Kaposi Mor Oktató Kórház | Kaposvár, 7400, Hungary
Emek Medical Center | Afula, 1834111, Israel
Barzilai Medical Center, Hematology Institute | Ashkelon, 78278, Israel
Carmel Medical Center | Haifa, 3436212, Israel
Hadassh Medical Organization | Jerusalem, 91120, Israel
Meir Medical Center | Kfar Saba, 4428164, Israel
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi | Bologna, 40138, Italy
Azienda Ospedaliera Universitaria San Martino | Genova, 16132, Italy
Kyungpook National University Hospital | Daegu, Daegu Gwang'yeogsi, 41944, Korea, Republic of
Severance Hospital | Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03722, Korea, Republic of
Samsung Medical Center | Seoul, 06351, Korea, Republic of
Catholic University of Korea Seoul Saint Mary's Hospital | Seoul, 06591, Korea, Republic of
Seoul National University Hospital | Seoul, 3080, Korea, Republic of
Maastricht University Medical Centre | Maastricht, Limburg, 6229 HX, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza | Brzozów, Podkarpacki, 36-200, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich | Chorzów, 41-500, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub | Lublin, 20-081, Poland
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii | Małogoskie, 31-501, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego | Poznań, 60-631, Poland
Policlinica de Diagnostic Rapid SA | Braşov, 500152, Romania
Spitalul Clinic Coltea | Bucuresti, 030171, Romania
Institutul Clinic Fundeni | Bucuresti, 22328, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuţă | Cluj-Napoca, 400124, Romania
Institutul Regional De Oncologie IASI | Iasi, 700483, Romania
Singapore General Hospital | Singapore, 169608, Singapore
Raffles Hospital | Singapore, 188770, Singapore
Hospital Germans Trias i Pujol | Badalona, Barcelona, 08916, Spain
Institut Hospital del Mar d'Investigacions Mèdiques | Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron | Barcelona, 8035, Spain
Hospital Universitario Ramón y Cajal | Madrid, 28034, Spain
Hospital Universitario 12 de Octubre | Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro Majadahonda | Madrid, 28222, Spain
Clínica Universidad de Navarra | Pamplona, 31008, Spain
Hospital de Día Quirónsalud Zaragoza | Zaragoza, 50012, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital | Kaohsiung, 88301, Taiwan
University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom
Imperial College Healthcare NHS Trust | London, W12 ONN, United Kingdom
Oxford University Hospitals NHS Trust | Oxford, OX3 7LJ, United Kingdom
Location Countries

Australia

Belgium

Bulgaria

Canada

Denmark

France

Germany

Hungary

Israel

Italy

Korea, Republic of

Netherlands

Poland

Romania

Singapore

Spain

Taiwan

United Kingdom

United States

Verification Date

2021-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Cohort 1: Study GS-US-352-0101

Type: Other

Description: Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-0101 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Label: Cohort 2: Study GS-US-352-1214

Type: Other

Description: Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1214 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Label: Cohort 3: Study GS-US-352-1154

Type: Other

Description: Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1154 until MMB receives regulatory approval and is commercially available, or development of the product ceases..

Label: Cohort 4: Study SRA-MMB-301

Type: Other

Description: Participants will continue to receive the same dosage regimen as in the previous MMB study SRA-MMB-301 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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