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MEK Inhibitor
Binimetinib + Palbociclib Before Surgery for Cancer
Phase < 1
Waitlist Available
Led By Christos Fountzilas
Research Sponsored by Roswell Park Cancer Institute
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 30 days post-treatment
Awards & highlights
Study Summary
This trial is testing the effects of two drugs on operable KRAS-positive lung, colorectal, or pancreatic cancer. The drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The drugs may also help the immune system fight the cancer.
Who is the study for?
Adults over 18 with KRAS-positive lung, colorectal, or pancreatic cancer that can be surgically removed. They must have good performance status (able to carry out daily activities), adequate organ function, and no severe concurrent diseases. Participants need to understand the study's nature and consent in writing. Women of childbearing potential and men must agree to effective contraception.Check my eligibility
What is being tested?
The trial is testing binimetinib and palbociclib before surgery on patients with operable KRAS-positive cancers. These drugs are believed to stop tumor growth by blocking enzymes needed for cell growth, potentially improving immune system access to tumors.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea, blood count changes leading to increased infection risk or bleeding problems, liver enzyme alterations suggesting liver stress or damage, muscle pain or weakness due possibly elevated creatine kinase levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Ki67 labeling index of > 70%
Incidence of adverse events
Secondary outcome measures
Gene expression analysis
Immune subsets within the pre and posttreatment tumor tissue
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (palbociclib, binimetinib)Experimental Treatment3 Interventions
Patients receive palbociclib PO QD and binimetinib PO BID for 14 days in the absence of disease progression or unacceptable toxicity. Within 1 week after last dose of study medication, patients undergo surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1100
Palbociclib
2017
Completed Phase 3
~3760
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,858 Total Patients Enrolled
Christos FountzilasPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
171 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a neuromuscular disorder that causes high levels of creatine kinase (CPK) in your body.You had a serious lung blood clot within the past 12 weeks, or a less serious one within the past 4 weeks, and are on a stable dose of blood thinners.You have another type of cancer that needs to be treated with medication.You have been diagnosed with HIV or AIDS.You have a hepatitis B or hepatitis C virus infection.You have had chronic inflammatory bowel disease or Crohn's disease that needed treatment within the past year.You are healthy enough to perform daily activities without restrictions or with some minor restrictions.You have a certain type of cancer called KRAS-positive mutant lung adenocarcinoma, colorectal, or pancreatic cancer that can be surgically removed.Your absolute neutrophil count is 1500 or higher.You have a measurable disease according to specific criteria for evaluating tumors.You have brain metastases or leptomeningeal carcinomatosis that are not under control, or require frequent medication or radiation. If you have had previous brain metastases, they must be stable without needing medication for at least 7 days before starting the study treatment.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal.You have received treatment with certain types of medications called CDK4/6 or MEK inhibitors before.You have a condition that affects how your body absorbs the study drugs. This could include ongoing digestive problems, recent bowel obstruction, or certain surgeries.Your hemoglobin level is at least 9 grams per deciliter.Your kidneys work well enough to filter out waste from your blood.You have certain heart problems, such as recent heart attacks, heart failure, low heart pumping function, uncontrolled high blood pressure, or significant heart rhythm issues.You have received any other cancer treatment within the 2 weeks before the study.You have not fully recovered from the side effects of your previous treatment, unless you have long-term stable conditions that are not expected to get better.Your platelet count should be at least 100,000 per microliter of blood.You have had pancreatitis in the last 6 months.Your AST and ALT levels should be less than or equal to two times the upper limit of normal.You have a history of a certain eye condition called retinal vein occlusion or have risk factors for developing it.You have an ongoing illness or infection, heart problems, or mental health issues that could make it hard for you to follow the study rules.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (palbociclib, binimetinib)
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 purpose is Palbociclib primarily used for?
"Palbociclib has been used to successfully treat malignant neoplasms, metastatic melanomas, and instances of braf v600e mutation."
Answered by AI
Have any former experiments explored the potential of Palbociclib?
"At present, 187 trials are running that involve Palbociclib. 19 of these live investigations have progressed to Phase 3. Tampa is the major hub for research on this medication; however, it can be found at 8216 locations throughout the world."
Answered by AI
To what extent is enrollment progressing in this clinical trial?
"True, the clinicaltrials.gov database indicates that enrollment for this trial is in progress since its initial posting on December 30th 2021 and subsequent updates as recent as May 11 2022. In total 24 people are needed for the single location study."
Answered by AI
Does this experimental research represent a pioneering effort?
"There are currently 187 ongoing Palbociclib trials in 58 countries and 1529 cities. This drug was first tested on 183 patients, sponsored by Pfizer back in 2011. Since then, 132 trials have been successfully concluded."
Answered by AI
Are there any open slots available to join this trial?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, initially posted on December 30th 2021, is presently recruiting participants. 24 volunteers are required across 1 medical centre to complete the study."
Answered by AI
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