Extended Access of Momelotinib in Adults With Myelofibrosis

Sponsor
Sierra Oncology, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03441113
Collaborator
(none)
400
107
4
103
3.7
0

Study Details

Study Description

Brief Summary

The primary objective of this study is to provide extended access and assess long-term safety 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-US-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. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Actual Study Start Date :
May 3, 2018
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Cohort 1: Study GS-US-352-0101

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.

Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
  • Other: Cohort 2: Study GS-US-352-1214

    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.

    Drug: MMB
    Tablet(s) administered orally once daily
    Other Names:
  • GS-0387
  • CYT387
  • Other: Cohort 3: Study GS-US-352-1154

    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..

    Drug: MMB
    Tablet(s) administered orally once daily
    Other Names:
  • GS-0387
  • CYT387
  • Other: Cohort 4: Study SRA-MMB-301

    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.

    Drug: MMB
    Tablet(s) administered orally once daily
    Other Names:
  • GS-0387
  • CYT387
  • Outcome Measures

    Primary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IC Irvine Health Orange California United States 92868
    2 Stanford Hospital and Clinics Stanford California United States 94305
    3 University of Colorado Cancer Center Aurora Colorado United States 80045
    4 Mayo Clinic Florida Jacksonville Florida United States 32224
    5 Moffitt Cancer Center Tampa Florida United States 33612
    6 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
    7 Northwest Oncology & Hematology - Rolling Meadows Rolling Meadows Illinois United States 60008
    8 Saint Agnes Hospital Baltimore Maryland United States 21229
    9 Dana-Farber Cancer Institute (DFCI) Boston Massachusetts United States 02215
    10 Mayo Clinic - Department of Hematology Rochester Minnesota United States 55905
    11 Washington University School of Medicine Siteman Cancer Center Saint Louis Missouri United States 63110
    12 Montefiore Medical Center Bronx New York United States 10467
    13 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    14 Mayo Clinic Building - Phoenix Milwaukee Wisconsin United States 53226
    15 Icon Cancer Care Wesley Hyde Park Queensland Australia 4812
    16 Flinders Medical Centre Adelaide South Australia Australia 5000
    17 Frankston Hospital Frankston Victoria Australia 3199
    18 The Alfred Hospital Melbourne Victoria Australia 3004
    19 Peter MacCallum Cancer Centre Parkville Victoria Australia 3050
    20 Royal Perth Hospital Perth Western Australia Australia 6160
    21 Ordensklinikum Linz Elisabethinen Linz Upper Austria Austria 4020
    22 Medizinische Universität Wien Wien Vienna Austria 1090
    23 Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan Brugge West-Vlaanderen Belgium 8000
    24 Ziekenhuis Netwerk Antwerpen Stuivenberg Antwerp Belgium 2060
    25 Universitaire Ziekenhuis Leuven Leuven Belgium 3000
    26 Centre Hospitalier Universitaire de Liège Site Sart Tilman Liège Belgium 4000
    27 UMHAT Dr. Georgi Stranski EAD Pleven Bulgaria 5800
    28 Multiprofile Hospital for Active Treatment Ruse Ruse Bulgaria 7002
    29 National Specialized Hospital for Active Treatment of Haematologic Diseases Sofia Bulgaria 1431
    30 University Multiprofile Hospital for Active Treatment St. Ivan Rilski Sofia Bulgaria 1431
    31 Research Institute of the McGill University Health Centre Montréal Quebec Canada H3H 2R9
    32 Sir Mortimer B. Davis Jewish General Hospital Montréal Canada H3T 1E2
    33 Princess Margaret Cancer Centre Toronto Canada M5G 2M9
    34 Aalborg University Hospital Aalborg Denmark 9000
    35 Gentofte Hospital Herlev Denmark 2730
    36 Hopital Saint-Louis Paris ILE-De-FRANCE France 75475
    37 Centre Hospitalier Le Mans Le Mans Pays De La Loire France 72037
    38 CHRU Huriez Lille Lille Cedex France 59020
    39 Institut Paoli Calmettes Marseille France 13273
    40 Hôpital Haut-Lévêque Pessac Cedex France 33604
    41 Centre Hospitalier Lyon Sud Pierre Bénite Cedex France 69495
    42 Institut Universitaire du Cancer Toulouse Cedex 9 France 31059
    43 Universitätsklinikum Aachen Aachen Nordrhein-Westfalen Germany 52074
    44 Universitätsklinikum Halle Halle Sachsen-Anhalt Germany 06120
    45 University Hospital of Cologne Cologne Germany 50937
    46 Universitätsklinikum Dresden Dresden Germany 01307
    47 Universitätsklinikum Leipzig Leipzig Germany 04103
    48 Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    49 Szent Borbála Kórház Tatabánya Komárom-Esztergom Hungary 2800
    50 Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet Budapest Pest Hungary 1097
    51 Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház Nyíregyháza Szabolcs-Szatmár-Bereg Hungary 4400
    52 Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia Budapest Hungary 1083
    53 Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek Debrecen Hungary 4032
    54 Somogy Megyei Kaposi Mor Oktató Kórház Kaposvár Hungary 7400
    55 Emek Medical Center Afula Israel 1834111
    56 Barzilai Medical Center, Hematology Institute Ashkelon Israel 78278
    57 Carmel Medical Center Haifa Israel 3436212
    58 Hadassh Medical Organization Jerusalem Israel 91120
    59 Meir Medical Center Kfar Saba Israel 4428164
    60 Azienda Ospedaliero - Universitaria Careggi Firenze Florence Italy 50134
    61 Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo Monza Monza E Brianza Italy 20900
    62 Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Pesaro E Urbino Italy 61121
    63 Azienda Ospedaliera Ordine Mauriziano di Torino Torino Turin Italy 10128
    64 Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi Bologna Italy 40138
    65 Azienda Ospedaliera Universitaria San Martino Genova Italy 16132
    66 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy 20122
    67 IRCCS Centro di Riferimento Oncologico di Basilicata Potenza Italy 85028
    68 Umberto I - Policlinico di Roma Roma Italy 00161
    69 Ospedale Policlinico Giambattista Rossi Borgo Roma Verona Italy 37134
    70 Inje University Haeundae Paik Hospital Busan Busan Gwang'yeogsi [Pusan-Kwangyokshi] Korea, Republic of 48108
    71 Kyungpook National University Hospital Daegu Daegu Gwang'yeogsi Korea, Republic of 41944
    72 Severance Hospital Seoul Seoul Teugbyeolsi [Seoul-T'ukpyolshi] Korea, Republic of 03722
    73 Samsung Medical Center Seoul Korea, Republic of 06351
    74 Catholic University of Korea Seoul Saint Mary's Hospital Seoul Korea, Republic of 06591
    75 Seoul National University Hospital Seoul Korea, Republic of 3080
    76 Maastricht University Medical Centre Maastricht Limburg Netherlands 6229 HX
    77 Szpital Wojewódzki w Opolu Opole Opolskie Poland 45-064
    78 Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Brzozów Podkarpacki Poland 36-200
    79 Uniwersyteckie Centrum Kliniczne Gdańsk Pomoskie Poland 80-952
    80 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich Chorzów Poland 41-500
    81 Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub Lublin Poland 20-081
    82 Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii Małogoskie Poland 31-501
    83 Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego Poznań Poland 60-631
    84 Policlinica de Diagnostic Rapid SA Braşov Romania 500152
    85 Spitalul Clinic Coltea Bucuresti Romania 030171
    86 Institutul Clinic Fundeni Bucuresti Romania 22328
    87 Institutul Oncologic Prof. Dr. Ion Chiricuţă Cluj-Napoca Romania 400124
    88 Spitalul Clinic Municipal Filantropia Craiova Craiova Romania 200143
    89 Institutul Regional De Oncologie IASI Iasi Romania 700483
    90 Singapore General Hospital Singapore Singapore 169608
    91 Raffles Hospital Singapore Singapore 188770
    92 Hospital Germans Trias i Pujol Badalona Barcelona Spain 08916
    93 Institut Hospital del Mar d'Investigacions Mèdiques Barcelona Spain 08003
    94 Hospital Universitari Vall d'Hebron Barcelona Spain 8035
    95 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    96 Hospital Universitario 12 de Octubre Madrid Spain 28041
    97 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
    98 Clínica Universidad de Navarra Pamplona Spain 31008
    99 Hospital de Día Quirónsalud Zaragoza Zaragoza Spain 50012
    100 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    101 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 88301
    102 National Taiwan University Hospital Taipei Taiwan 100
    103 Chang Gung Memorial Hospital - Linkou Branch Taoyuan Taiwan 333
    104 University Hospitals Bristol and Weston NHS Foundation Trust Bristol England United Kingdom BS2 8ED
    105 University Hospital of Wales Cardiff United Kingdom CF14 4XW
    106 Imperial College Healthcare NHS Trust London United Kingdom W12 ONN
    107 Oxford University Hospitals NHS Trust Oxford United Kingdom OX3 7LJ

    Sponsors and Collaborators

    • Sierra Oncology, Inc.

    Investigators

    • Study Director: Sierra Oncology, Inc., Sierra Oncology, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sierra Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT03441113
    Other Study ID Numbers:
    • SRA-MMB-4365
    • 2017-004350-42
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022