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SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
This study is to test a new investigational drug (one that is not approved by the US Food and Drug Administration) called cobomarsen (MRG-106). Cobomarsen belongs to a class of drugs called micro-RNA inhibitors and is intended to enter the cancer cells and block the activity of another molecule called miR-155-5p, which may be important for the cancer cells to live and divide. Cobomarsen¿s effect on mycosis fungoides will be compared in this study with the effect of vorinostat, which is a drug that has been approved in the United States and Australia for treatment of CTCL.
Primary: The primary objective of the study is to evaluate the efficacy of cobomarsen in subjects with MF. Secondary: - Investigate the safety and tolerability of cobomarsen in subjects with MF. - Characterize the population pharmacokinetics (PK) of cobomarsen in subjects with MF. Exploratory: - Characterize pharmacodynamic (PD) effects of cobomarsen.
Cobomarsen (); SAHA (Vorinostat); Vorinostat (); Zolinza (Vorinostat); suberoylanilide hydroxamic acid (Vorinostat)