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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

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

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,800 Total Patients Enrolled

Brown UniversityLead Sponsor

456 Previous Clinical Trials

563,059 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,201,036 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03905889 — Phase 1

Kidney Cancer Research Study Groups: Experimental Abemaciclib and Sunitinib

Kidney Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03905889 — Phase 1

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03905889 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacant positions in this research endeavor for volunteers?

"This experiment is not currently seeking volunteers. It was first posted on June 5th 2019 and last revised on January 5th 2022. In the event that you are considering other trials, there are 2583 clinical studies actively recruiting individuals with carcinoma renal cell cancer, along with 122 pertinent Abemaciclib research projects searching for enrollees presently."

Answered by AI

What past research exists regarding Abemaciclib's efficacy?

"Abemaciclib is currently the subject of 122 active medical studies and 27 are in their final phase. The primary location for research with this drug appears to be Surat, Gujarat, although there are 8677 other sites engaging with clinical trials involving Abemaciclib."

Answered by AI

What is the cap on patient participation in this trial?

"At this point, recruitment for the clinical trial in question has been closed. The study was posted on June 5th 2019 and amended most recently on January 5th 2022. For those interested in similar studies, there are 2583 trials actively recruiting participants with carcinoma or renal cell cancer, as well as 122 studies involving Abemaciclib that require participants."

Answered by AI

What medical conditions are commonly treated with Abemaciclib?

"Abemaciclib can be employed to treat a variety of malignancies, including: advanced hr + her2 - breast cancer, metastatic pancreatic neuroendocrine tumors and advanced renal cell carcinoma (ARCC)."

Answered by AI

Has the FDA granted approval for Abemaciclib?

"Due to the limited clinical information available, Abemaciclib's safety rating is estimated to be a 1. This Phase 1 trial only provides preliminary evidence for both efficacy and safety."

Answered by AI

What results are researchers attempting to ascertain with this experiment?

"Eli Lilly and Company, the clinical trial sponsor, has outlined their primary objective as assessing Continued Toxicity of Abemaciclib and Sunitinib at the maximum tolerated dose over 8 days, 15 days 21days 28 days 35 days 42days 56 days 63days 77days 84day 98 (at beginning and weekly during cycles 1 & 2; day 1&15 of cycle 3-5). Secondary objectives include Overall Survival rate from initiation to completion of drug regimen with follow up time period, Progression Free Survival tracked via RECIST v1.1 criteria., plus Median overall survival number for time frame between start date to end date."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma

Sheldon Holder, MD, PhD 2019. "A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03905889.

All > Metastatic Renal Cell Carcinoma > Sutent