Extended Access of Momelotinib in Adults With Myelofibrosis | NCT03441113

NCT03441113

ID	Type	Description
2017-004350-42	EudraCT Number
SRA-MMB-4365	Other Identifier	Sierra Oncology, Inc.
219627	Other Identifier	GlaxoSmithKline

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Study GS-US-352-0101	Other	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
Cohort 2: Study GS-US-352-1214	Other	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
Cohort 3: Study GS-US-352-1154	Other	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
Cohort 4: Study SRA-MMB-301	Other	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

Name	Type	Description	Arm Group Labels	Other Names
MMB	Drug	Tablet(s) administered orally once daily	Cohort 1: Study GS-US-352-0101 Cohort 2: Study GS-US-352-1214 Cohort 3: Study GS-US-352-1154

Outcomes Module

Primary Outcomes

Measure	Description	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Scottsdale	Arizona	53226	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37517413	Derived	Gerds AT, Verstovsek S, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Oh S, Klencke BJ, Yu J, Donahue R, Kawashima J, Mesa R. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. Lancet Haematol. 2023 Sep;10(9):e735-e746. doi: 10.1016/S2352-3026(23)00174-6. Epub 2023 Jul 27.
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IPD Sharing Statement Module

ID	Term
D009369	Neoplasms
D055728	Primary Myelofibrosis

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases