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Histone Deacetylase Inhibitor

Binimetinib + Belinostat for Uveal Melanoma

Phase 2
Recruiting
Led By Ahmad Tarhini, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed
Male or female, aged >/= 18 years old
Must not have
Participants with clinically significant cardiovascular or cerebrovascular disease: History of cerebrovascular accident or transient ischemic attack within past 6 months, Uncontrolled hypertension, Myocardial infarction, CABG or unstable angina within the past 6 Months, New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months, Clinically significant peripheral vascular disease within past 6 months, Pulmonary embolism, DVT, or other thromboembolic event within past 6 months, PT INR >1.5 unless the patient is on full-dose warfarin
Participants must not have an active infection requiring current treatment with parenteral antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing two drugs, Binimetinib and Belinostat, in people with a type of eye cancer that has spread. The goal is to see if these drugs can stop the cancer from growing or make it shrink.

Who is the study for?
Adults over 18 with metastatic uveal melanoma can join this trial. They should have a life expectancy of more than 3 months, measurable disease, and normal organ/marrow function. Participants must not have had MEK or HDAC inhibitors before and should be free from active brain metastases. Contraception is required during the study.
What is being tested?
The trial is testing a combination of two drugs, Binimetinib and Belinostat, to see if they can shrink or halt the growth of tumors in patients with metastatic uveal melanoma.
What are the potential side effects?
Possible side effects may include fatigue, nausea, skin rash, changes in blood pressure or heart rhythm disturbances due to Binimetinib; and fatigue, nausea, vomiting, diarrhea due to Belinostat. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with metastatic uveal melanoma.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My blood counts and organ functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had serious heart or blood vessel problems in the last 6 months.
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I am not currently on IV antibiotics for an infection.
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I have had serious eye conditions not fixed by treatment.
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I have taken steroids for lung inflammation or ILD.
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I haven't had any new drug trials or radiation for my eye melanoma in the last 4 weeks.
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I can take pills and do not have major stomach or intestine problems affecting drug absorption.
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I had major surgery over 4 weeks ago and have recovered without any significant infections.
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I have a serious or non-healing wound, ulcer, or bone fracture.
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My heart is healthy with no recent major issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate
Secondary study objectives
Overall Survival
Progression Free Survival

Side effects data

From 2022 Phase 3 trial • 702 Patients • NCT02928224
78%
Diarrhoea
68%
Dermatitis acneiform
59%
Nausea
54%
Fatigue
51%
Vomiting
51%
Dry Skin
43%
Pyrexia
43%
Anaemia
41%
Decreased appetite
38%
Abdominal pain
38%
Constipation
35%
Dyspnoea
32%
Vision blurred
30%
Blood creatine increased
30%
Blood creatine phosphokinase increased
24%
Arthralgia
24%
Myalgia
24%
Skin fissures
22%
Back Pain
22%
Dizziness
19%
Malaise
19%
Urinary tract infection
19%
Headache
19%
Aspartate aminotransferase increased
16%
Asthenia
16%
Stomatitis
16%
Oedema peripheral
16%
PPE syndrome
16%
Hypomagnesaemia
16%
Rash maculo-papular
16%
Palmar-planar erythrodysaesthesia
16%
Chills
16%
Paronychia
16%
Rash pustular
16%
Alanine aminotransferase increased
16%
Dysgeusia
16%
Peripheral sensory neuropathy
14%
Cough
14%
Abdominal pain upper
14%
Infusion-related reaction
14%
Ejection fraction decreased
14%
Dry eye
11%
Trichiasis
11%
Pollakiuria
11%
Vitreous floaters
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Macular oedema
8%
Visual impairment
8%
Rhinitis allergic
8%
Infusion related reaction
8%
Hypokalaemia
8%
Hypertrichosis
8%
Iron deficiency
8%
Nasopharyngitis
8%
Weight decreased
8%
Flank pain
8%
Proteinuria
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Trichomegaly
5%
Nervous system disorder
5%
Restless legs syndrome
5%
Infection
5%
Pleural effusion
5%
Hypocalcaemia
5%
Hypophosphataemia
5%
Wound
5%
Rectal haemorrhage
5%
Musculoskeletal pain
5%
Anal haemorrhage
5%
Ascites
5%
Colitis
5%
Abdominal pain lower
5%
Nail disorder
5%
Pruritus generalised
5%
Bone pain
5%
Musculoskeletal chest pain
5%
Chorioretinopathy
5%
Urinary incontinence
5%
Insomnia
5%
Gastroesophageal reflux disease
5%
Abdominal distension
5%
Eczema
5%
Cystitis
5%
Renal failure
5%
Conjunctivitis
5%
Syncope
5%
Dehydration
5%
Dry Mouth
5%
Skin hyperpigmentation
5%
Muscle spasms
5%
Erythema
5%
Retinal detachment
5%
Pulmonary embolism
5%
Dysphonia
5%
Haematuria
5%
Blood creatinine increased
5%
Depression
5%
Palpitations
3%
Kidney infection
3%
Large intestinal ulcer hemorrhage
3%
Urinary tract infection bacterial
3%
Large intestinal ulcer
3%
Melanocytic naevus
3%
Epistaxis
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Tumour pain
3%
Streptococcal infection
3%
Alopecia
3%
Upper respiratory tract infection
3%
Skin papilloma
3%
Large intestine perforation
3%
Bacterial sepsis
3%
Cholangitis
3%
Urinary tract obstruction
3%
Confusional state
3%
Device occlusion
3%
Back pain
3%
Rhabdomyolysis
3%
Colon cancer
3%
Sepsis
3%
Acute kidney injury
3%
Large intestine ulcer
3%
Neutropenia
3%
Bacteria sepsis
3%
Hydronephrosis
3%
Neuropathy peripheral
3%
Abdominal abscess
3%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combined Safety Lead-in
Phase 3: Triplet Arm
Phase 3: Doublet Arm
Phase 3: Control Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Binimetinib + BelinostatExperimental Treatment2 Interventions
Participants will receive binimetinib by mouth two times a day, every day during each cycle. Each cycle will last for 21 days. Participants will receive belinostat by intravenous infusion on days 1 through 5 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1250
Belinostat
2006
Completed Phase 2
~430

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Uveal Melanoma treatments often target specific pathways involved in tumor growth and survival. Binimetinib, a MEK inhibitor, works by blocking the MEK enzyme, which is part of the MAPK/ERK pathway that promotes cell division and survival. By inhibiting this pathway, Binimetinib can reduce tumor growth and proliferation. Belinostat, an HDAC inhibitor, interferes with histone deacetylases, enzymes that modify proteins associated with DNA, leading to changes in gene expression that can induce cancer cell death and inhibit tumor growth. These mechanisms are crucial for Uveal Melanoma patients as they offer targeted approaches to disrupt cancer cell function and potentially improve treatment outcomes.

Find a Location

Who is running the clinical trial?

Acrotech Biopharma LLCIndustry Sponsor
27 Previous Clinical Trials
3,807 Total Patients Enrolled
Acrotech Biopharma Inc.Industry Sponsor
30 Previous Clinical Trials
5,189 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
559 Previous Clinical Trials
144,565 Total Patients Enrolled

Media Library

Belinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05170334 — Phase 2
Uveal Melanoma Research Study Groups: Binimetinib + Belinostat
Uveal Melanoma Clinical Trial 2023: Belinostat Highlights & Side Effects. Trial Name: NCT05170334 — Phase 2
Belinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05170334 — Phase 2
~1 spots leftby Dec 2024