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CDK4/6 Inhibitor

Abemaciclib + MK-6482 for Renal Cell Carcinoma

Phase 1
Waitlist Available
Led By Toni K Choueiri, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal organ and marrow function as defined below:
Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with clear cell component. Patients with extensive sarcomatoid histology are accepted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks during the first six months of the study, then every 12 weeks, in both arms up to 21 months
Awards & highlights

Study Summary

This trial will study whether the combination of these drugs is safe and effective in treating ccRCC.

Who is the study for?
This trial is for adults with advanced or metastatic renal cell carcinoma that has a clear cell component. Participants must have previously tried and not responded well to at least one anti-VEGFR therapy and an immune checkpoint inhibitor. They should be in relatively good health, able to take oral medication, and willing to use contraception.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of two drugs, Abemaciclib alone or combined with MK-6482, in slowing down the growth of clear cell renal cell carcinoma (ccRCC). It will involve patients who meet specific health criteria.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer medications such as fatigue, nausea, liver issues reflected by blood tests changes, low blood counts leading to increased infection risk or bleeding problems. Specific side effects related to these drugs will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organ and bone marrow functions are normal.
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My kidney cancer is advanced, cannot be surgically removed, and has clear cell features.
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My liver tests are within normal range, except I have liver cancer.
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My kidneys are functioning well enough for treatment.
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I can swallow pills.
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I agree to use birth control during the study.
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I am 18 years old or older.
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I am able to have a new tumor biopsy unless it's unsafe for me.
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I can care for myself but may not be able to do active work.
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I have tried at least one anti-VEGFR therapy and one immune checkpoint inhibitor for my kidney cancer without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks during the first six months of the study, then every 12 weeks, in both arms up to 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks during the first six months of the study, then every 12 weeks, in both arms up to 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Abemaciclib and MK-6482/Arm 2
Objective response rate (ORR) Abemaciclib and MK-6482/Arm 2
Objective response rate (ORR) Abemaciclib/Arm 1
Secondary outcome measures
Upper arm
Upper arm
Upper arm
+4 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%
Neutropenia
18%
White blood cell count decreased
15%
Alopecia
14%
Weight decreased
14%
Dry mouth
14%
Platelet count decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Alanine aminotransferase increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
2%
Cellulitis
2%
Pleural effusion
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%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pneumonitis
1%
Pneumothorax
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Abemaciclib-Arm 1Experimental Treatment1 Intervention
Arm 1 Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks, in both Arm 1 and Arm 2.
Group II: Abemaciclib and MK-6482-Arm 2Experimental Treatment2 Interventions
Arm 2 Arm 2 will start enrolling only after there is experience with Arm 1 to see what abemaciclib effects are when given alone, Dose escalation will occur following a 3+3 design. Abemaciclib will be taken 2X daily uring 28 day study cycle MK-6482 will be taken 1x daily during 28 day study cycle Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks, in both arms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,074 Previous Clinical Trials
340,343 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,592 Total Patients Enrolled
Toni K Choueiri, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
177 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04627064 — Phase 1
Renal Cell Carcinoma Research Study Groups: Abemaciclib and MK-6482-Arm 2, Abemaciclib-Arm 1
Renal Cell Carcinoma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04627064 — Phase 1
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04627064 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI
~7 spots leftby Dec 2024