Quisinostat for Eye Cancer

Overseen By CRS Cutaneous

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

Must not be taking: CYP3a4/A5 inhibitors

Disqualifiers: Additional malignancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

63 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you cannot be on medications that strongly affect certain liver enzymes (CYP3a4/A5 and CYP2C9) without approval. If you're on such medications, you may need to stop them, but this will be discussed with the trial's Sponsor-Investigator.

How does the drug Quisinostat differ from other treatments for eye cancer?

Quisinostat is unique because it is being explored for its potential to treat eye cancer, specifically uveal melanoma, by targeting specific cancer cell markers and pathways, which is different from traditional treatments that may not focus on these specific mechanisms. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Jose Lutzky, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with high-risk uveal melanoma, a type of eye cancer. Participants should have completed initial treatment but are at risk of the cancer spreading. Specific eligibility details aren't provided, so interested individuals should contact the study team for full criteria.

Inclusion Criteria

Life expectancy of greater than 3 months.

Ability to understand and the willingness to sign a written informed consent document.

I am older than 18 years.

Exclusion Criteria

Use of other investigational drugs within 28 days or five half-lives, whichever is shorter, with a minimum of 14 days from the last dose preceding the first dose of study treatment and during the study.

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to quisinostat.

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the treating Investigator.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Quisinostat treatment for up to 17 cycles, each cycle lasting 21 days, for a total treatment period of up to 51 weeks

51 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment until disease progression

Up to 2 years

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 36 months

Treatment Details

Interventions

• Quisinostat

Trial Overview The trial is testing quisinostat to see if it can prevent high-risk uveal melanoma from spreading after initial treatment. The effects on patients' conditions will be closely monitored to assess efficacy and safety.

Participant Groups

Group I: Quisinostat Treatment Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Viriom

Industry Sponsor

Trials

17

Recruited

3,900+

Joseph and Florence Mandel Family Foundation

Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Intravitreal implants: drug carriers and carriers of hope?]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

INTRAVITREAL FLUOCINOLONE ACETONIDE IMPLANT FOR RADIATION RETINOPATHY: Report of Preliminary Findings. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Fluocinolone acetonide sustained drug delivery device for chronic central retinal vein occlusion: 12-month results. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

1,4-dihydroxy quininib modulates the secretome of uveal melanoma tumour explants and a marker of oxidative phosphorylation in a metastatic xenograft model. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Preventing relapse in non-infectious uveitis affecting the posterior segment of the eye - evaluating the 0.2 μg/day fluocinolone acetonide intravitreal implant (ILUVIEN®). [2022]