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

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

Sponsors

Lead Sponsor: Sierra Oncology, Inc.

Source Sierra Oncology, Inc.
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.

Overall Status Completed
Start Date April 30, 2014
Completion Date December 6, 2018
Primary Completion Date December 6, 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse event profile of momelotinib as measured by incidence and severity of adverse events Up to 4 years
Laboratory abnormality profile of momelotinib as measured by incidence and severity of clinical laboratory abnormalities Up to 4 years
Secondary Outcome
Measure Time Frame
Overall survival Up to 4 years
Progression-free survival Up to 4 years
Leukemia-free survival Up to 4 years
Rate of RBC transfusion Up to 4 years
Duration of splenic response (Cohorts 1 and 2 only) Up to 4 years
Duration of transfusion independence response (Cohorts 1 and 2 only) Up to 4 years
Duration of anemia response (Cohorts 1 and 2 only) Up to 4 years
Transfusion response rate (Cohort 4 only) Up to 4 years
Enrollment 87
Condition
Intervention

Intervention Type: Drug

Intervention Name: Momelotinib

Description: Momelotinib tablets administered orally once daily

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gilead Study Director Study Director Gilead Sciences
Location
Facility:
| Scottsdale, Arizona, United States
| Orange, California, United States
| Stanford, California, United States
| Whittier, California, United States
| Jacksonville, Florida, United States
| Baltimore, Maryland, United States
| Boston, Massachusetts, United States
| Ann Arbor, Michigan, United States
| Rochester, Minnesota, United States
| Saint Louis, Missouri, United States
| Bronx, New York, United States
| New York, New York, United States
| Cleveland, Ohio, United States
| Houston, Texas, United States
| Salt Lake City, Utah, United States
| Frankston, Victoria, Australia
| Parkville, Victoria, Australia
| Toronto, Ontario, Canada
| Montreal, Quebec, Canada
| La Tronche, France
| Paris, France
| Minden, Germany
Location Countries

Australia

Canada

France

Germany

United States

Verification Date

January 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Cohort 1

Type: Experimental

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

Label: Cohort 2

Type: Experimental

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

Label: Cohort 3

Type: Experimental

Description: 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.

Label: Cohort 4

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov