Spots Global Cancer Trial Database for A Phase 2 Study of RO7490677 In Participants With Myelofibrosis
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Trial Identification
Brief Title: A Phase 2 Study of RO7490677 In Participants With Myelofibrosis
Official Title: A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), Or Post-Essential Thrombocythemia MF (Post-ET MF)
Study ID: NCT01981850
Study Description
Brief Summary: 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.
Detailed Description: Stage 1 of this study has completed. Stage 1 was an open-label, Simon two stage, Phase 2 study to determine the efficacy and safety of two different dose schedules of RO7490677 in participants with PMF and post ET/PV MF. There were two treatment cohorts, each assigned to one of two dose schedules receiving either single-agent RO7490677 or RO7490677 in combination with ruxolitinib. Participants were assigned to a weekly or every four week dosing schedule by the investigator. Stage 2 is a randomized, double-blind Phase 2 study to determine the efficacy and safety of three different doses of RO7490677 in participants with PMF and post ET/PV MF. Participants will be randomized to one of three doses: 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of RO7490677. This is the second stage of an adaptive design study as defined in FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, February 2010. Modifications to dose levels, schedule, and regimen have been made in Stage 2 based on data from Stage 1.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Cancer Center, Phoenix, Arizona, United States
Stanford Cancer Institute, Palo Alto, California, United States
Emory Hospital, Atlanta, Georgia, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mount Sinai Medical Center, New York, New York, United States
Weill Cornell Medical Center, New York, New York, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Providence Health Care, Vancouver, British Columbia, Canada
The Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hospital Saint-Louis, Paris, , France
University Medical Center RWTH Aachen, Aachen, , Germany
Johannes Wesling Academic Medical Center, Minden, , Germany
Hadassah Medical Centre, Jerusalem, , Israel
Meir Medical Centre, Kfar Saba, , Israel
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Marche Nord Hospital, Pesaro, , Italy
Erasmus Medical Center, Rotterdam, Zuid Holland, Netherlands
Radboud University Medical Center, Nijmegen, , Netherlands
Guy's and St. Thomas' Hospital, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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