A Phase 2 Study of RO7490677 In Participants With Myelofibrosis

Status Completed

Clinical Trial 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.

Clinical Trial 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 This is the second stage of an adaptive design study as defined in FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, February 2010.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. ;

Study Design

Related Conditions & MeSH terms

Polycythemia
Polycythemia Vera
Post-Essential Thrombocythemia Myelofibrosis
Primary Myelofibrosis
Thrombocythemia, Essential
Thrombocytosis

Clinical Trial Details

NCT number	NCT01981850
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Completed
Phase	Phase 2
Start date	October 1, 2013
Completion date	July 10, 2020

View Details

See also
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