Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extended Access of Momelotinib in Adults With Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03441113
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sierra Oncology, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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), who are currently receiving treatment with MMB (available as 100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease.

Condition or disease Intervention/treatment Phase
Post-polycythemia Vera Myelofibrosis (Post-PV MF) Primary Myelofibrosis (PMF) Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) Drug: MMB Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants Who Had Access to, and Received the Intervention [ Time Frame: Up to 96 Weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441113


  Show 67 Study Locations
Sponsors and Collaborators
Sierra Oncology, Inc.
Investigators
Layout table for investigator information
Study Director: Sierra Oncology, Inc. Sierra Oncology, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Sierra Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03441113     History of Changes
Other Study ID Numbers: GS-US-352-4365
2017-004350-42 ( EudraCT Number )
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocytosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
 Neoplasms by Site
Neoplasms
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action