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CDK4/6 Inhibitor
Abemaciclib + Sunitinib for Kidney Cancer
Phase 1
Waitlist Available
Led By Sheldon Holder, MD, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1. This is defined in at least one dimension as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT, MRI or calipers by clinical exam
Has completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy, at least 3-4 weeks from prior VEGFR/mTOR/ or immunotherapy or any other tyrosine kinase inhibitor (TKI) therapy, and at least 4 weeks for treatment with investigational drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing the safety of a new combination drug regimen for treating advanced and metastatic renal cell carcinoma. The study will enroll participants in a 3x3 dose escalation study design to determine the maximal tolerated dose of the new drug combination. The study will then enroll additional participants in a dose expansion phase to further evaluate the safety and tolerability of the new drug combination.
Who is the study for?
This trial is for adults with metastatic renal cell carcinoma, predominantly clear cell type. They must be able to swallow pills, have measurable disease, and a life expectancy over 3 months. Prior treatments are allowed if recovery is complete. Women of childbearing age and men must use contraception. Some patients need prior immunotherapy or targeted therapy based on their risk status.Check my eligibility
What is being tested?
The study tests the combination of two oral drugs, Abemaciclib and Sunitinib, to find the safest high dose without severe side effects (MTD) in kidney cancer patients. It has two parts: finding the MTD first then giving more people this dose to check its safety and how it works in the body.See study design
What are the potential side effects?
Possible side effects include issues from both drugs like diarrhea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver function changes, mouth sores, high blood pressure, hand-foot syndrome (redness/pain/swelling), heart rhythm changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured by scans or physical exam.
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I've recovered from side effects of my last cancer treatment and waited the required time before starting a new one.
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I can swallow pills.
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I am a woman who can have children, not pregnant, and will use birth control during and 30 days after the study.
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My major organs are functioning well, according to recent tests.
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My cancer has spread to other parts of my body.
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I am able to care for myself and perform daily activities.
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My kidney cancer is mostly clear cell type and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continued Toxicity assessment of the maximum tolerated dose (i.e the recommended Phase II dose) of Abemaciclib and Sunitinib as determined from the from dose escalation phase.
Maximum tolerated dose (MTD)
Pharmacokinetic Assessment of Abemaciclib and Sunitinib trough levels at steady state
Secondary outcome measures
Disease Control Rate
Duration of Response
Median Overall Survival
+3 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental Abemaciclib and SunitinibExperimental Treatment2 Interventions
For the dose escalation phase, Subjects will receive a 21-day cycle of continuous oral daily Sunitinib in combination with Abemaciclib every 12 hours for 14 days followed by 7 days off. Using a traditional 3 x 3 study design assessing dose limiting toxicity, if the initial prescribed dosing of these 2 medications (Dose Level 1) is tolerated by the first 3 subjects, the study will pause for a 30 day time period between cohorts to assess toxicity. If no dose limiting toxicity is identified, the next cohort of 3 new subjects will be treated at the next higher dose level (Dose Level 2). If the original cohort treated at Dose Level 1 do not tolerate the combination of medications, the medication regimen will be modified to a lower dose (Dose Level - 1). A dose expansion phase is included which will evaluate the combination of Abemaciclib in combination with Sunitinib when given at the maximum tolerated dose as determined from the from dose escalation phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Sunitinib
2014
Completed Phase 3
~4380
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
497 Previous Clinical Trials
2,799,948 Total Patients Enrolled
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,234 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,624 Previous Clinical Trials
3,216,902 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a CDK4/6 inhibitor like ribociclib.I have a history of lung scarring or restrictive lung disease.I have previously used a PIM1 kinase inhibitor.I haven't had chemotherapy in the last 4 weeks or radiotherapy in the last week.I have no active cancer except for certain skin cancers or treated cancers with no signs for 3 years.I have a condition that affects how drugs work in my body.I have a tumor that can be measured by scans or physical exam.My high blood pressure is not controlled despite treatment.I have a brain tumor or cancer spread to my brain from another type.I have a history of HIV, hepatitis B, or hepatitis C.I am currently on IV antibiotics for an infection.I can provide a tissue sample for analysis or will undergo a biopsy.My kidney cancer is mostly non-clear cell type.I have kidney cancer and either progressed after ipilimumab and nivolumab, refused it, or can't have it.I have advanced kidney cancer and have either tried cabozantinib, refused it, or can't take it.I am allergic to medications similar to Abemaciclib or Sunitinib.I've recovered from side effects of my last cancer treatment and waited the required time before starting a new one.I am a male either surgically sterile or using approved birth control during and 30 days post-study.My brain metastases are stable, treated, and I'm on low or no steroids.I can swallow pills.I am a woman who can have children, not pregnant, and will use birth control during and 30 days after the study.My major organs are functioning well, according to recent tests.I have a history of heart rhythm issues related to long QT syndrome.I have diabetes and had more than 2 ketoacidosis episodes in the last year.My cancer has spread to other parts of my body.I am able to care for myself and perform daily activities.My kidney cancer is mostly clear cell type and has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Abemaciclib and Sunitinib
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.
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