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Binimetinib + Belinostat for Uveal Melanoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT02928224Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Binimetinib + Belinostat
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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