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Abemaciclib + MK-6482 for Renal Cell Carcinoma
Study Summary
This trial will study whether the combination of these drugs is safe and effective in treating ccRCC.
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 2018 Phase 2 trial • 132 Patients • NCT02102490Trial Design
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Who is running the clinical trial?
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- You need to have at least 100,000 platelets per microliter of blood.You have a disease that can be measured using a specific medical guideline.My organ and bone marrow functions are normal.I have previously been treated with a HIF-2α inhibitor.You have a sufficient number of a type of white blood cell called neutrophils.I am willing and able to follow the study rules.I haven't had major surgery in the last 4 weeks or still recovering from one.I am currently on blood thinners like warfarin.My kidney cancer is advanced, cannot be surgically removed, and has clear cell features.Your hemoglobin level is at least 10 grams per deciliter.I had major radiation therapy over a month ago or small area radiation within the last two weeks without severe side effects.I currently have an active infection (bacterial, fungal, or viral).I have not treated my blood clot in a vein or lung, or had one in the last 2 weeks.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.My liver tests are within normal range, except I have liver cancer.My kidneys are functioning well enough for treatment.I have a stomach or intestine problem that affects how I absorb pills.I haven't taken any small molecule drugs recently or have recovered from their side effects.I have had a previous transplant of an organ or stem cells from a donor.I have not had a major heart event in the last 6 months.I am not pregnant or breastfeeding.I have a serious lung problem that affects my daily life.I have previously been treated with CDK4/6 inhibitors.I can swallow pills.Your oxygen level is less than 92% when measured with a blood test or a device that clips on your finger.I stopped all biologic therapy including therapeutic antibodies 28 days before starting the trial.I do not have an active Hepatitis B or C infection.Your bilirubin levels are within a certain range, unless you have a specific condition called Gilbert disease.I haven't had another cancer with a high risk of spreading in the last 2 years.I agree to use birth control during the study.I am 18 years old or older.I am able to have a new tumor biopsy unless it's unsafe for me.I can care for myself but may not be able to do active work.Your urine protein/creatinine ratio should be less than or equal to 2.I have tried at least one anti-VEGFR therapy and one immune checkpoint inhibitor for my kidney cancer without success.
- Group 1: Abemaciclib and MK-6482-Arm 2
- Group 2: Abemaciclib-Arm 1
- 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
Have any new recruits been taken on for this experiment?
"Affirmative, the details on clinicaltrials.gov confirm that this experiment is actively recruiting participants. It was made public on December 31st 2020 and most recently updated on May 16th 2022; 40 test subjects are needed from 2 various sites."
What medical conditions is Abemaciclib commonly utilized to treat?
"Abemaciclib is primarily used as a therapeutic agent against malignant neoplasms. Additionally, it may be beneficial for conditions such as disease, von hippel lindau syndrome and cases of high risk recurrence."
Is this experiment a pioneering endeavor?
"Abemaciclib has 107 live studies spread out over 1491 cities and 51 countries, the earliest of which began in 2009. This initial study was sponsored by Eli Lilly & Company and included 220 participants that it successfully brought through Phase 1 drug approval stage. 32 subsequent trials have been conducted since then."
What goals are scientists hoping to achieve through this research?
"The clinical trial sponsor, Eli Lilly and Company, has recorded the main objective for this study to be Objective Response Rate (ORR) Abemaciclib and MK-6482/Arm 2. This metric will be measured from treatment start up until disease recurrence or progression relative to measurements taken in a 21 month time frame. Additionally, other secondary outcomes such as Duration of Response (DOR) Abemaciclib and MK-6482/Arm 2 using RECIST criteria version 1.1 guidelines, Overall Survival (OS) Abemaciclib / Arm 1 with Kaplan Meier estimates given at selected intervals along with their"
Has Abemaciclib undergone regulatory scrutiny and earned certification from the FDA?
"Early clinical data suggests that Abemaciclib is likely safe, thus receiving a score of 1 on the scale."
What is the headcount of individuals taking part in this experiment?
"Affirmative. The clinical trial is actively recruiting according to the information posted on clinicaltrials.gov, which was first published in December 2020 and last updated in May of this year. 40 participants need to be gathered from two medical sites for the study's completion."
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