SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
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. 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 study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries. Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, 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. Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.
Key facts
- Study ID
- NCT03713320
- Run by
- miRagen Therapeutics, Inc.
- People needed
- 37
- Starts
- 2019-04-02
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2022-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Alabama at Birmingham — Birmingham, Alabama, United States
- Mayo Clinic — Phoenix, Arizona, United States
- City of Hope — Duarte, California, United States
- UCLA — Los Angeles, California, United States
- Chao Family Comprehensive Cancer Center at University of California, Irvine — Orange, California, United States
- Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
- Mayo Clinic — Jacksonville, Florida, United States
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Rochester Skin Lymphoma Medical Group — Fairport, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Inova Schar Cancer Institute — Fairfax, Virginia, United States
- University of Washington — Seattle, Washington, United States
- Concord Repatriation General Hospital — Concord, New South Wales, Australia
- Westmead Hospital — Westmead, New South Wales, Australia
- Linear Clinical Research — Nedlands, Australia
- University Clinic UZ Leuven — Leuven, Belgium
- Cross Cancer Institute — Edmonton, Alberta, Canada
Full record on ClinicalTrials.gov
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