A Phase 2 Study of RO7490677 In Participants With Myelofibrosis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT01981850
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • RO7490677 — BIOLOGICAL
    IV infusion
  • Ruxolitinib — DRUG
    IV infusion

Study Details

RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue. The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.

Key Dates

Start date
Oct 1, 2013
Status verified
Dec 2021
Primary completion
Jul 10, 2020
Completion
Jul 10, 2020

Study Design

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

Arms

  • Experimental: Stage 1: Cohort 1 Weekly
    Participants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
  • Experimental: Stage 1: Cohort 1 Every 4 Weeks
    Paricipants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
  • Experimental: Stage 1: Cohort 2 Weekly
    Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
  • Experimental: Stage 1: Cohort 2 Every 4 Weeks
    Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
  • Experimental: Stage 2: Cohort 1 0.3mg/kg Every 4 Weeks
    Participants will be treated with single agent RO7490677 at a dose of 0.3 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
  • Experimental: Stage 2: Cohort 2 3mg/kg Every 4 Weeks
    Participants will be treated with single agent RO7490677 at a dose of 3.0 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
  • Experimental: Stage 2: Cohort 3 10mg /kg Every 4 Weeks
    Participants will be treated with single agent RO7490677 at a dose of 10 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.

Primary Outcome Measure

Stage 1 Main Phase: Overall Response Rate (ORR) [ Time Frame: Up until and including completion of 6 cycles. Each cycle is 28 days. ]

Locations (11)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer CenterPhoenixArizona85054-
Stanford Cancer InstitutePalo AltoCalifornia94304-
Emory HospitalAtlantaGeorgia30322-
University of Maryland Medical CenterBaltimoreMaryland21201-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-2800-
Mount Sinai Medical CenterNew YorkNew York10029-
Weill Cornell Medical CenterNew YorkNew York10065-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Vanderbilt University Medical CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Cancer Center· Phoenix, AZStanford Cancer Institute· Palo Alto, CAEmory Hospital· Atlanta, GAUniversity of Maryland Medical Center· Baltimore, MDDana-Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MI

Related Studies