Extended Access of Momelotinib in Adults With Myelofibrosis
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
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:
|
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:
|
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- 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
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.- SRA-MMB-4365
- 2017-004350-42