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| Name | Class |
|---|---|
| Viriom | INDUSTRY |
| Joseph and Florence Mandel Family Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quisinostat Treatment Group | Experimental | Participants will receive up to Quisinostat treatment for up to 17 cycles, each cycle lasting 21 days, for a total treatment period of up to 51 weeks. Participants will be followed for up to 2 years after end of treatment until disease progression. Total participation duration is about three years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quisinostat | Drug | Participants will receive 12 mg of Quisinostat via capsule to be taken orally three times per week of each 21 day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as the elapsed time in months from the date of study entry until disease progression, which will include both local/regional recurrences and distant metastatic disease recurrences or death, whichever occurs first. Alive patients who have not had an event will be censored at the date of last disease assessment documenting that the patient was free of progression. PFS will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Estevez | Contact | 305-243-8376 | cme101@med.miami.edu | |
| CRS Cutaneous | Contact | 305-243-0326 | CRSCutaneous@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jose Lutzky, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C541788 | quisinostat |
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| Up to 36 months |
| Overall Survival (OS) | Overall survival (OS) is defined as the elapsed time in months from start of study entry to death. OS will be determined to date of death from any cause. Surviving patients will be censored at the date of last contact. | Up to 36 months |
| Identification of Site of First Recurrence As Measured By Percentage | Identification of the most common site of first recurrence (SFR) among participants will be reported as a percentage. SFR is defined as the anatomical location of the first documented recurrent lesion and further subcategorized as hepatic and extra-hepatic. | Up to 36 months |
| Number of Participants Experiencing Treatment Emergent Adverse Events (AEs) | The number of participants experiencing treatment-emergent adverse events (AEs), including treatment-related adverse events (AEs) will be reported. AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion. | Up to 13 months |
| Number of Participants Experiencing Treatment Emergent Serious Adverse Events (SAEs) | The number of participants experiencing treatment-emergent adverse events (SAEs), including treatment-related serious adverse events (SAEs) will be reported. SAEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion. | Up to 13 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |