Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Gilead Sciences
Study ID
NCT01369498
Phase
PHASE2
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Simtuzumab — DRUG
    Simtuzumab administered intravenously over approximately 30 minutes every 2 weeks
  • Ruxolitinib — DRUG
    In Stage 2, participants will be on a stable dose of ruxolitinib

Study Details

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF). The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.

Key Dates

Start date
Jun 30, 2011
Status verified
Jun 2020
Primary completion
Jun 5, 2014
Completion
Sep 24, 2014

Study Design

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

Arms

  • Experimental: Simtuzumab 200 mg
    Participants in Stage 1 of study will receive simtuzumab 200 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.
  • Experimental: Simtuzumab 700 mg
    Participants in Stage 1 of study will receive simtuzumab 700 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.
  • Experimental: Simtuzumab 200 mg+Ruxolitinib
    In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 200 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.
  • Experimental: Simtuzumab 700 mg+Ruxolitinib
    In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 700 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.

Primary Outcome Measure

Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score [ Time Frame: Baseline; Week 24 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259-
Stanford University Medical centerStanfordCalifornia94305-
Washington University in St. LouisSt LouisMissouri63110-
Oncology Hematology Care Clinical TrialsCincinnatiOhio--
Cleveland ClinicClevelandOhio--
Tennessee OncologyNashvilleTennessee--
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic· Scottsdale, AZStanford University Medical center· Stanford, CAWashington University in St. Louis· St Louis, MOOncology Hematology Care Clinical Trials· Cincinnati, OHCleveland Clinic· Cleveland, OHTennessee Oncology· Nashville, TN

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