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Kinase Inhibitor
Binimetinib + Encorafenib for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Andrew E Hendifar
Research Sponsored by Academic and Community Cancer Research United
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 25 months
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat pancreatic cancer with a somatic BRAF V600E mutation. The drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with pancreatic cancer that has a specific mutation (BRAF V600E). Participants must have had previous treatment, be able to swallow pills, and provide consent. They should not be pregnant or nursing and must agree to use contraception. People with certain health conditions or those taking prohibited medications are excluded.Check my eligibility
What is being tested?
The effectiveness of two drugs, Binimetinib and Encorafenib, is being tested on patients with pancreatic cancer carrying the BRAF V600E mutation. The study aims to see if these drugs can stop tumor growth better than standard treatments by blocking enzymes needed for cell growth.See study design
What are the potential side effects?
Potential side effects include fatigue, skin rash, nausea, vomiting, abdominal pain, vision changes like blurred vision or retinal vein occlusion (RVO), increased blood pressure, liver enzyme changes indicating liver damage, muscle pain or weakness due to elevated creatine kinase (CK) levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) at 24 Weeks
Secondary outcome measures
Duration of Response
Number of Patients With Grade 3+ Adverse Events
Overall Survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (encorafenib, binimetinib)Experimental Treatment2 Interventions
Patients receive encorafenib PO QD and binimetinib PO BID on days 1-25. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Encorafenib
FDA approved
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,130 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,147 Total Patients Enrolled
Andrew E HendifarPrincipal InvestigatorAcademic and Community Cancer Research United
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your local pathology lab has confirmed that you have pancreatic cancer.Women who could become pregnant need to have a negative pregnancy test within 7 days before joining the study.Your average corrected QT interval is longer than 480 milliseconds.You had radiation treatment less than 14 days ago, or you haven't recovered from the side effects of the treatment. If you had palliative radiation, it must have been completed at least 7 days before starting the study treatment.You have a history of eye problems that could lead to a blocked vein in the retina, or have conditions that increase the risk of this happening.You have had a stroke, blood clot, or related events within the past 12 weeks.You have a specific BRAF V600E mutation in your tumor.You have a specific type of mutation in the BRAF gene called non-V600E or a fusion involving the BRAF gene in your tumor.You have previously received treatment with specific drugs like encorafenib, dabrafenib, vemurafenib, binimetinib, trametinib, or cobimetinib.You have a confirmed hepatitis B or hepatitis C virus infection.You have a neuromuscular disorder that causes high levels of creatine kinase (CK) in your body.You are allergic to any part of binimetinib or encorafenib.Your heart's pumping ability is less than or equal to 50%, as measured by a special heart scan or ultrasound.You have had pancreatitis in the past.A certified lab needs to confirm that you have a specific mutation (BRAF V600E) in your tumor before you can join the study.Your body has enough infection-fighting white blood cells (neutrophils).Your total bilirubin level must be less than 1.5 times the upper limit of normal.You have a weakened immune system, are HIV positive, and are currently taking antiretroviral medication. However, if you are HIV positive but your immune system is not weakened, you can still participate in this trial.You have an ongoing illness, such as an infection or heart problem, or a mental health or social issue that might make it hard for you to follow the study's rules.You have had a serious heart condition like a heart attack or needed heart surgery within the last 6 months.Your blood pressure is consistently very high, even with medication.You have had cancer within the past two years, except for certain types of early-stage cancers or if you are currently receiving hormonal therapy after treatment for breast or prostate cancer.You have received cancer treatment, such as chemotherapy or immunotherapy, within the last two weeks (or four weeks for antibody-based therapy).You have not fully recovered from the side effects of previous treatment, except for stable chronic conditions that are not expected to improve.You have brain metastases that are causing symptoms and are not under control.You have a condition that affects how your stomach and intestines work or how your body absorbs medicine, such as a recent bowel obstruction or ongoing vomiting or diarrhea.Your disease has gotten worse or you couldn't tolerate at least one treatment for your advanced disease.Your cancer has come back and spread less than 12 weeks after finishing chemotherapy, or it has spread after completing chemotherapy for advanced disease within the same time frame.You have a disease that can be measured.You have a score of 0, 1, or 2 on the ECOG performance status form.Your platelet count should be at least 75,000 per cubic millimeter of blood, measured within the last 14 days before joining the study.Your hemoglobin level should be at least 9.0 grams per deciliter.Your liver enzyme levels are within a certain range, and if you have liver spread of cancer, they can be slightly higher.Your liver function tests must show normal levels of aminotransferase, unless you have cancer that has spread to the liver, in which case slightly higher levels may be allowed.Your kidney function test must show that your kidneys are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (encorafenib, binimetinib)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
How many individuals are contributing to this research endeavor?
"The study mandates that 29 suitable candidates partake in the trial, with enrolment locations including Johns Hopkins University/Sidney Kimmel Cancer Centre and Dana-Farber Cancer Institute."
Answered by AI
Is this trial unique in its methodology and application?
"Binimetinib has been part of the medical landscape since 2011, when a trial sponsored by Pfizer was completed. This initial study involving 183 people resulted in Binimetinib receiving Phase 2 approval and now there are 63 separate trials happening across 41 countries with 1256 cities hosting them."
Answered by AI
Has the FDA validated Binimetinib as viable medical therapy?
"Binimetinib has been evaluated with preliminary data on safety, so it was assigned a score of 2. Unfortunately, there is not enough evidence to support its efficacy at this time."
Answered by AI
Are there a significant number of medical centers in the U.S. currently conducting this trial?
"This trial is currently recruiting patients at 5 distinct sites, which are found in Baltimore, Boston and Phoenix along with a few other cities. To reduce the strain of travelling to appointments, folks should choose the location closest to them when registering for this medical study."
Answered by AI
To what degree have there been prior studies on Binimetinib?
"In 2011, the first clinical trials of binimetinib commenced at LMU Klinikum der Universität. There are now 29 completed studies and 63 ongoing experiments being conducted in Baltimore, Maryland and other locations around the globe."
Answered by AI
Is there an open enrollment period for this scientific experiment?
"According to clinicaltrials.gov, this investigation is actively seeking participants. The trial was initially listed on November 16th 2020 and has been adjusted as recently as August 16th 2022."
Answered by AI
What medical applications are Binimetinib typically prescribed for?
"Individuals with the BRAF V600K mutation, metastatic melanoma, and unresectable melanoma may benefit from treatment using binimetinib."
Answered by AI
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