Clinical trial NCT02124746: Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
Official title: Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Post-Essential Thrombocythemia Myelofibrosis
Polycythemia Vera
Essential Thrombocythemia
Keywords: Primary Myelofibrosis
Post Polycythemia Vera Myelofibrosis
Post Essential Thrombocythemia Myelofibrosis
Polycythemia Vera
Essential Thrombocythemia
blood disorders
Lead sponsor: Sierra Oncology LLC - a GSK company
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities
timeFrame: 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:
measure: Splenic Response Rate
timeFrame: 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.
measure: Duration of Splenic Response
timeFrame: 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.
measure: Transfusion Independence Response Rate
timeFrame: 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.
measure: Duration of Transfusion Independence Response
timeFrame: 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.
measure: Anemia Response Rate
timeFrame: 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.
measure: Duration of Anemia Response
timeFrame: 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.
measure: Rate of RBC Transfusion
timeFrame: From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154.
measure: Overall Survival
timeFrame: From baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib.
measure: Progression-Free Survival
timeFrame: From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib.
measure: Leukemia-Free Survival
timeFrame: From baseline in the parent study until the date of the last assessment, up to 30 days following permanent discontinuation of momelotinib.
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Orange
country: United States
state: California
city: Stanford
country: United States
state: California
city: Whittier
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Frankston
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: La Tronche
country: France
city: Paris
country: France
city: Minden
country: Germany
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: