PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
Stopped early · Phase 2
Conditions studied: Cutaneous T-Cell Lymphoma/Mycosis Fungoides
In brief
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.
Key facts
- Study ID
- NCT03837457
- Run by
- miRagen Therapeutics, Inc.
- People needed
- 8
- Starts
- 2019-10-01
- Expected to finish
- 2020-07-27
- Last updated by the study team
- 2020-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- The Ohio State University and Wexner Medical Center — Columbus, Ohio, United States
- University of Washington/Seattle Cancer Care Alliance — Seattle, Washington, United States
- University Hospital Leuven — Leuven, Belgium
- Hopital Saint Andre, CHU de Bordeaux — Bordeaux, France
- Hopital Saint-Louis — Paris, France
- Hopital Charles Nicolle, CHU de Rouen — Rouen, France
Full record on ClinicalTrials.gov
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