Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Sierra Oncology LLC - a GSK company
Study ID
NCT01969838
Phase
PHASE3
Status
Completed

Conditions

  • Post-Essential Thrombocythemia Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Momelotinib — DRUG
    Momelotinib tablet administered orally once daily
  • Ruxolitinib — DRUG
    Ruxolitinib tablets administered orally twice daily
  • Placebo to match momelotinib — DRUG
    Placebo to match momelotinib tablets administered orally once daily
  • Placebo to match ruxolitinib — DRUG
    Placebo to match ruxolitinib tablets administered orally twice daily

Study Details

This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

Key Dates

Start date
Dec 6, 2013
Status verified
May 2023
Primary completion
Sep 12, 2016
Completion
May 2, 2019

Study Design

Enrollment
432 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Momelotinib
    Participants will receive momelotinib plus placebo to match ruxolitinib.
  • Active Comparator: Ruxolitinib
    Participants will receive ruxolitinib plus placebo to match momelotinib.

Primary Outcome Measure

Splenic Response Rate at Week 24 [ Time Frame: Week 24 ]

Locations (11)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-EscondidoCalifornia--
-StanfordCalifornia--
-JacksonvilleFlorida--
-AtlantaGeorgia--
-ChicagoIllinois--
-BaltimoreMaryland--
-BostonMassachusetts--
-St LouisMissouri--
-DurhamNorth Carolina--
-SeattleWashington--

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