Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Primary MyelofibrosisPost-Polycythemia VeraPost-Essential Thrombocythemia Myelofibrosis
Interventions
DRUG

Momelotinib

"In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels in successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily with doses taken approximately 12 hours apart. Doses will be escalated by 50 mg BID in successive cohorts of 3 subjects per dose level. Subjects will be evaluated weekly for the first cycle, every 2 weeks during cycle 2, then monthly for 4 cycles for a total of 6 cycles.~In the dose confirmation phase of the study (Part 2), subjects will be evaluated every 2 weeks during the first treatment cycle, and then monthly for 5 cycles for a total of 6 cycles."

Trial Locations (6)

32224

Mayo Clinic, Jacksonville

77030

MD Anderson Cancer Center, The University of Texas, Houston

84108

Huntsman Cancer Institute at the University of Utah, Salt Lake City

85259

Mayo Clinic, Scottsdale

M5G 2M9

Princess Margaret Hospital, Toronto

H3T 1E2

Jewish General Hospital, Montreal

All Listed Sponsors
lead

Sierra Oncology LLC - a GSK company

INDUSTRY

NCT01423058 - Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis | Biotech Hunter | Biotech Hunter