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History of Changes for Study: NCT03441113
Extended Access of Momelotinib in Adults With Myelofibrosis
Latest version (submitted June 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 15, 2018 None (earliest Version on record)
2 March 6, 2018 Study Status and Oversight
3 March 29, 2018 Study Status
4 May 8, 2018 Recruitment Status, Study Status and Contacts/Locations
5 May 29, 2018 Contacts/Locations and Study Status
6 June 15, 2018 Study Status and Contacts/Locations
7 July 11, 2018 Contacts/Locations and Study Status
8 August 7, 2018 Study Status and Contacts/Locations
9 September 4, 2018 Study Status and Contacts/Locations
10 September 27, 2018 Contacts/Locations and Study Status
11 November 2, 2018 Study Status and Contacts/Locations
12 November 30, 2018 Contacts/Locations and Study Status
13 December 24, 2018 Contacts/Locations and Study Status
14 January 30, 2019 Contacts/Locations, Sponsor/Collaborators, Study Status, Study Identification and Study Description
15 February 25, 2019 Contacts/Locations and Study Status
16 April 1, 2019 Study Status and Contacts/Locations
17 May 6, 2019 Study Status and Contacts/Locations
18 December 12, 2019 Arms and Interventions, Study Status, Eligibility, Outcome Measures, Study Design, Study Description and Study Identification
19 February 25, 2020 Study Status
20 April 12, 2021 Study Status
21 June 11, 2021 Study Status and Contacts/Locations
22 June 21, 2021 Contacts/Locations and Study Status
23 July 8, 2021 Study Status and Contacts/Locations
24 July 15, 2021 Contacts/Locations and Study Status
25 July 30, 2021 Contacts/Locations and Study Status
26 August 13, 2021 Study Status and Contacts/Locations
27 August 27, 2021 Contacts/Locations and Study Status
28 September 17, 2021 Study Status and Contacts/Locations
29 September 28, 2021 Contacts/Locations and Study Status
30 October 15, 2021 Study Status, Contacts/Locations and Study Description
31 November 15, 2021 Study Status and Contacts/Locations
32 January 6, 2022 Contacts/Locations and Study Status
33 February 3, 2022 Study Status and Contacts/Locations
34 February 14, 2022 Contacts/Locations and Study Status
35 February 25, 2022 Contacts/Locations and Study Status
36 March 7, 2022 Contacts/Locations and Study Status
37 April 8, 2022 Contacts/Locations and Study Status
38 April 22, 2022 Contacts/Locations and Study Status
39 April 28, 2022 Contacts/Locations and Study Status
40 May 2, 2022 Study Description and Study Status
41 May 12, 2022 Contacts/Locations and Study Status
42 June 9, 2022 Contacts/Locations and Study Status
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Study NCT03441113
Submitted Date:  February 15, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: GS-US-352-4365
Brief Title: Extended Access of Momelotinib in Adults With Myelofibrosis
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)
Secondary IDs: 2017-004350-42 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2018
Overall Status: Not yet recruiting
Study Start: March 2018
Primary Completion: June 2020 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: February 15, 2018
First Submitted that
Met QC Criteria:
February 15, 2018
First Posted: February 22, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
February 15, 2018
Last Update Posted: February 22, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 Gilead sponsored studies GS-US-352-0101 (NCT01969838), GS-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), who are currently receiving treatment with MMB (available as 100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease.
Detailed Description:
Open or close this module Conditions
Conditions: Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Primary Myelofibrosis (PMF)
Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 for a maximum duration of 96 weeks.
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
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 for a maximum duration of 96 weeks.
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
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 for a maximum duration of 96 weeks.
Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants Who Had Access to, and Received the Intervention
[ Time Frame: Up to 96 Weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Key Inclusion Criteria:

  • Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
  • 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.

Open or close this module Contacts/Locations
Central Contact Person: Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Study Officials: Gilead Study Director
Study Director
Gilead Sciences
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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