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Histone Deacetylase Inhibitor

Vorinostat for Uveal Melanoma

Phase 2
Waitlist Available
Led By Alexander N Shoushtari
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial looks at vorinostat as a treatment for melanoma that has spread to other parts of the body. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?
Adults with metastatic uveal melanoma (eye melanoma that has spread) can join this trial. They must have measurable disease, acceptable organ function tests, and a life expectancy over 3 months. Participants need to agree to use contraception and cannot be pregnant or breastfeeding. Those with certain serious health conditions or taking specific medications are excluded.Check my eligibility
What is being tested?
The trial is testing Vorinostat's effectiveness in treating metastatic uveal melanoma by inhibiting enzymes needed for tumor cell growth. It includes laboratory biomarker analysis to monitor the response and requires prior progression on other therapies.See study design
What are the potential side effects?
Vorinostat may cause side effects such as fatigue, digestive issues, changes in blood counts leading to increased infection risk, and potential harm to an unborn child; hence contraception is required during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate in patients with uveal melanoma
Secondary outcome measures
Incidence of toxicities
Overall survival
Progression free survival
Other outcome measures
BAP1 mutation status
GNA11 mutation status
Gnaq mutation status

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102
57%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Decreased appetite
40%
Vomiting
29%
Dyspnoea
24%
Constipation
20%
Weight decreased
18%
Tumour pain
18%
Cough
15%
Pleural mesothelioma malignant advanced
14%
Anaemia
12%
Pyrexia
9%
Insomnia
9%
Dry mouth
9%
Blood creatinine increased
9%
Abdominal pain
8%
Back pain
8%
Dysgeusia
7%
Dizziness
7%
Oedema peripheral
7%
Thrombocytopenia
7%
Headache
6%
C-reactive protein increased
6%
Dehydration
6%
Musculoskeletal pain
5%
Malaise
4%
Pneumonia
4%
Anxiety
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
Bladder cancer
1%
Non-cardiac chest pain
1%
Overdose
1%
Pneumothorax
1%
Sepsis
1%
Confusional state
1%
General physical health deterioration
1%
Pericarditis
1%
Disseminated intravascular coagulation
1%
Death
1%
Ascites
1%
Dysphagia
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (vorinostat)Experimental Treatment2 Interventions
Patients receive vorinostat PO BID for 3 days weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
2014
Completed Phase 3
~1600

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,361 Total Patients Enrolled
Institut Curie ParisUNKNOWN
Memorial Sloan Kettering Cancer CenterOTHER
1,944 Previous Clinical Trials
589,711 Total Patients Enrolled

Media Library

Vorinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01587352 — Phase 2
Uveal Melanoma Research Study Groups: Treatment (vorinostat)
Uveal Melanoma Clinical Trial 2023: Vorinostat Highlights & Side Effects. Trial Name: NCT01587352 — Phase 2
Vorinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01587352 — Phase 2
~1 spots leftby Dec 2024