NCT02124746

Brief Summary

This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
5 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

April 30, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2021

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4.6 years

First QC Date

April 24, 2014

Results QC Date

June 11, 2020

Last Update Submit

June 14, 2023

Conditions

Primary MyelofibrosisPost-Polycythemia Vera MyelofibrosisPost-Essential Thrombocythemia MyelofibrosisPolycythemia VeraEssential Thrombocythemia

Keywords

Primary MyelofibrosisPost Polycythemia Vera MyelofibrosisPost Essential Thrombocythemia MyelofibrosisPolycythemia VeraEssential Thrombocythemiablood disorders

Outcome Measures

Primary Outcomes (1)

  • Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities

    Long-term safety and tolerability profile of momelotinib based on safety data (adverse events and selected hematology and chemistry laboratory parameters) collected after the first dose of momelotinib in the parent study.

    From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.

Secondary Outcomes (10)

  • Splenic Response Rate

    From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

  • Duration of Splenic Response

    From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

  • Transfusion Independence Response Rate

    From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

  • Duration of Transfusion Independence Response

    From baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

  • Anemia Response Rate

    From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

  • +5 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

Participants previously enrolled in Study CCL09191E will receive momelotinib for approximately 4 years.

Drug: Momelotinib

Cohort 2

EXPERIMENTAL

Participants previously enrolled in Study YM387-II-02 will receive momelotinib for approximately 4 years.

Drug: Momelotinib

Cohort 3

EXPERIMENTAL

Participants previously enrolled in Study GS-US-354-0101 will receive momelotinib for up to 4 years. Cohort 3 was closed and all enrolled participants were discontinued from this study because parent Study GS-US-354-0101 was terminated.

Drug: Momelotinib

Cohort 4

EXPERIMENTAL

Participants previously enrolled in Study GS-US-352-1672 will receive momelotinib for approximately 4 years.

Drug: Momelotinib

Interventions

MomelotinibDRUG

Momelotinib tablets administered orally once daily

Also known as: GS-0387, CYT387
Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24 weeks of study GS-US-352-1672
  • Able to comprehend and willing to sign informed consent form

You may not qualify if:

  • Known hypersensitivity to momelotinib, its metabolites, or formulation excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Whittier, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Frankston, Victoria, Australia

Location

Unknown Facility

Parkville, Victoria, Australia

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

La Tronche, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Minden, Germany

Location

MeSH Terms

Conditions

Primary MyelofibrosisPolycythemia VeraThrombocythemia, EssentialHematologic Diseases

Interventions

N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHemic and Lymphatic DiseasesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Limitations and Caveats

Cohort 3 was discontinued and excluded from the safety and efficacy analyses. The survival analyses were subject to a high level of censoring.

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

April 30, 2014

Primary Completion

December 6, 2018

Study Completion

December 6, 2018

Last Updated

June 18, 2023

Results First Posted

February 5, 2021

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)DE(1)CA(2)US(15)FR(2)