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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
Participant must be free of active brain metastasis by contrast-enhanced CT/MRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study
Must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for metastatic uveal melanoma to see if it can make tumors shrink or stop growing.
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.Check my eligibility
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.See study design
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 belowSelect...
I do not have active brain cancer, and any previous brain metastases have been treated.
Select...
I have been diagnosed with metastatic uveal melanoma.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
My blood counts and organ functions are within normal ranges.
Select...
I am on a stable dose of blood thinners without any bleeding issues.
Select...
I will use effective birth control during and for 3 months after the study.
Select...
I have uveal melanoma and may have had treatments, but not with MEK or HDAC inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
Secondary outcome measures
Overall Survival
Progression Free Survival
Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT0292822478%
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%
Oedema peripheral
16%
Stomatitis
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%
Vitreous floaters
11%
Pollakiuria
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Weight decreased
8%
Proteinuria
8%
Rhinitis allergic
8%
Iron deficiency
8%
Nasopharyngitis
8%
Macular oedema
8%
Infusion related reaction
8%
Hypertrichosis
8%
Visual impairment
8%
Hypokalaemia
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Rectal haemorrhage
5%
Hypophosphataemia
5%
Pruritus generalised
5%
Bone pain
5%
Trichomegaly
5%
Restless legs syndrome
5%
Urinary incontinence
5%
Musculoskeletal pain
5%
Hypocalcaemia
5%
Nervous system disorder
5%
Ascites
5%
Abdominal pain lower
5%
Nail disorder
5%
Colitis
5%
Infection
5%
Musculoskeletal chest pain
5%
Chorioretinopathy
5%
Pleural effusion
5%
Wound
5%
Anal haemorrhage
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%
Back pain
3%
Large intestinal ulcer hemorrhage
3%
Urinary tract infection bacterial
3%
Melanocytic naevus
3%
Kidney infection
3%
Large intestinal ulcer
3%
Tumour pain
3%
Upper respiratory tract infection
3%
Large intestine perforation
3%
Cholangitis
3%
Streptococcal infection
3%
Device occlusion
3%
Skin papilloma
3%
Alopecia
3%
Bacterial sepsis
3%
Rhabdomyolysis
3%
Confusional state
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Urinary tract obstruction
3%
Epistaxis
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
~1100
Belinostat
2006
Completed Phase 2
~430
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
5,147 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,460 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active brain cancer, and any previous brain metastases have been treated.I have been diagnosed with metastatic uveal melanoma.I have had serious heart or blood vessel problems in the last 6 months.I am not currently on IV antibiotics for an infection.I am 18 years old or older.I am fully active or can carry out light work.I have had serious eye conditions not fixed by treatment.I have taken steroids for lung inflammation or ILD.My blood counts and organ functions are within normal ranges.I don't have any health conditions that would interfere with the study.I haven't had any new drug trials or radiation for my eye melanoma in the last 4 weeks.I haven't had a stroke or mini-stroke in the last 6 months.I am on a stable dose of blood thinners without any bleeding issues.I can take pills and do not have major stomach or intestine problems affecting drug absorption.You must have a disease that can be measured using a specific method called RECIST version 1.1.I had major surgery over 4 weeks ago and have recovered without any significant infections.I will use effective birth control during and for 3 months after the study.I have a serious or non-healing wound, ulcer, or bone fracture.My heart is healthy with no recent major issues.I haven't had any major abdominal issues like fistula, perforation, or abscess in the last 4 weeks.I have no other cancers, or have been cancer-free for over 3 years, except for certain skin cancers or in situ cancers.I have uveal melanoma and may have had treatments, but not with MEK or HDAC inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Binimetinib + Belinostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the Binimetinib FDA status?
"Binimetinib scored a 2 on our safety scale at Power. This is due to the fact that, while there is data indicating that it is safe, there is currently no evidence suggesting that it is an effective medication."
Answered by AI
How is Binimetinib most commonly used?
"Binimetinib is most often used to treat patients with a braf v600e mutation. However, it can also be an effective treatment for other conditions such as braf v600k mutation and relapsed peripheral t-cell lymphoma."
Answered by AI
Is this an original study?
"Since 2012, there have been 66 ongoing studies into Binimetinib's efficacy. These trials are taking place in 1102 different cities located across 39 countries. The first trial was sponsored by Pfizer and included 189 patients back in 2012. After this initial study, Phase 1 & 2 drug approval was given to Binimetinib."
Answered by AI
How many test subjects are participating in this experiment?
"That is correct. The clinicaltrials.gov website verifies that this trial, which was first advertised on December 8th 2021, is still looking for enrollees. So far, 1 centre has signed up and they are hoping to welcome 32 patients in total."
Answered by AI
Are there any other completed or ongoing studies that test Binimetinib?
"Binimetinib is being studied in 66 different clinical trials, 3 of which are currently in Phase 3. The majority of research facilities for this medication are located in Orange City, Florida; however, there are 3011 total locations running these sorts of tests."
Answered by AI
Are subjects still being enrolled in this experiment?
"That is correct, the clinical trial mentioned is still open and recruiting patients. According to the information on clinicaltrials.gov, the trial was posted on December 8th 2021 and last updated June 21st of this year. They are hoping to enroll 32 individuals at a single site."
Answered by AI
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