A Phase 2 interventional study of Resminostat (4SC-201) in Hodgkin's Lymphoma, sponsored by 4SC AG. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-16.
Sponsored by 4SC AG · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 37 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →4SC AG is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
oral administration
Drug: Resminostat (4SC-201)
oral administration
Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma.
Time frame: 12 weeks
Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)
Time frame: 12 weeks
Assessment of the overall survival (OS)
Time frame: 12 weeks
Determination of progression free survival (PFS), including radiological and symptomatic progression
Time frame: 12 weeks
Determination of time to progression (TTP), including objective and symptomatic progression
Time frame: 12 weeks
Determination of duration of response (DOR)
Time frame: 12 weeks
Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing
Time frame: 12 weeks
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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4SC AG