Phase 2 Trial of Adjuvant Quisinostat in High-Risk Uveal Melanoma
Summary
The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading. The researchers want to find out the effects that quisinostat has on participants' condition.
Arms & interventions
- DrugQuisinostat
Participants will receive 12 mg of Quisinostat via capsule to be taken orally three times per week of each 21 day cycle.
Outcome measures
Primary
Distant metastasis-free survival (DMFS) Rate
The distant metastasis-free survival (DMFS) rate among participants will be reported. DMFS is defined as the elapsed time in months from the date of study entry until the appearance of distant metastases or death, whichever occurs first. Participants who have not had an event will be censored at the date of last disease assessment documenting the patient was free of disease metastases. DMFS will be assessed from start of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 36 months
Secondary
Progression-free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Identification of Site of First Recurrence As Measured By Percentage
Time frame: Up to 36 months
Number of Participants Experiencing Treatment Emergent Adverse Events (AEs)
Time frame: Up to 13 months
Number of Participants Experiencing Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Up to 13 months
Eligibility criteria
Study locations (1)
University of Miami
Miami, Florida, 33136