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CDK4/6 Inhibitor
Abemaciclib for Liposarcoma
Phase 3
Recruiting
Led By Mark Dickson, MD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
ECOG Performance Status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new drug against placebo to see if it helps people with a certain disease. If the new drug doesn't work, patients will be able to try it anyway.
Who is the study for?
Adults with advanced dedifferentiated liposarcoma, measurable disease progression, and an ECOG Performance Status of 0 or 1 can join. They must be able to swallow pills, have recovered from prior treatments, and use effective birth control. Excluded are those who need urgent chemotherapy, have had certain recent surgeries or therapies including CDK4 inhibitors like abemaciclib, severe concurrent diseases, resectable disease for cure intent, pregnancy/breastfeeding women, known hypersensitivity to abemaciclib or untreated central nervous system disease.Check my eligibility
What is being tested?
This Phase 3 trial tests the drug Abemaciclib against a placebo in patients with advanced dedifferentiated liposarcoma. If their condition worsens on placebo they can switch to open-label Abemaciclib. The study is double-blind meaning neither participants nor researchers know who gets the real drug versus placebo until after the results.See study design
What are the potential side effects?
Abemaciclib may cause fatigue, diarrhea, low blood cell counts increasing infection risk; liver problems; blood clots; and potential harm to unborn babies when taken by pregnant women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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I have recovered from chemotherapy side effects, except for hair loss or mild nerve pain.
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I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the progression-free survival of patients treated with abemaciclib versus placebo
Secondary outcome measures
To determine PFS after crossover for patients initially randomized to placebo
To determine overall survival
To determine the objective response rate by RECIST 1.1
Side 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AbemaciclibExperimental Treatment1 Intervention
Abemaciclib will be administered 200mg orally twice a day. Each cycle is 28 days.
Group II: Placebo ArmPlacebo Group1 Intervention
Patients will be randomized 1:1 and will receive placebo if they are randomized to the placebo arm of the study. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,846 Total Patients Enrolled
1 Trials studying Liposarcoma
131 Patients Enrolled for Liposarcoma
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,452 Total Patients Enrolled
1 Trials studying Liposarcoma
33 Patients Enrolled for Liposarcoma
Mark Dickson, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
123 Total Patients Enrolled
2 Trials studying Liposarcoma
123 Patients Enrolled for Liposarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any stomach or intestine problems that affect how I absorb pills.I can take pills by mouth.I do not have a slow-growing type of liposarcoma.I have a history of serious heart conditions, including fainting due to heart issues, dangerous irregular heartbeats, or sudden cardiac arrest.If you're a woman of childbearing age, you must use a very effective form of birth control like an IUD or barrier method. If you choose condoms, you should also use a sperm-killing gel or cream for extra protection.My cancer has grown or spread recently.I have a brain condition that hasn't been treated yet.I haven't been in a clinical trial or used an experimental device recently.I am not taking any drugs that interact with abemaciclib.I am 18 years old or older.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.My cancer is a type of liposarcoma that has come back or spread.I am fully active or can carry out light work.My cancer can potentially be cured by surgery.I have a tumor that can be measured on a scan, taken within the last 28 days.I have recovered from chemotherapy side effects, except for hair loss or mild nerve pain.I agree to use effective birth control during and 3 weeks after treatment.I haven't had major surgery in the last 3 weeks or have fully recovered from recent surgery.I am not pregnant or nursing.You are allergic to abemaciclib.My organs are working well.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I do not urgently need strong chemotherapy for large tumors, as decided by my doctor.I have previously been treated with drugs like abemaciclib or palbociclib.I've had treatment for brain metastases and show no signs of worsening.I have not had any other cancers within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib
- Group 2: Placebo Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 other research studies have included Abemaciclib?
"The first clinical trial for abemaciclib was conducted in 2009. If you would like to learn more about the sites where this trial is being offered, you can call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) or speak to your personal physician. There have been 18268 completed clinical trials in total. Currently, there are 96 live clinical trials, with many of them located in New york, New York."
Answered by AI
Has this clinical trial been conducted before?
"Abemaciclib has 96 ongoing studies in 41 countries and 1273 cities. The first study began in 2009 and was sponsored by Eli Lilly and Company. That Phase 1 trial had 220 participants and completed in 2009. Since then, there have been 18268 clinical trials."
Answered by AI
Has Abemaciclib been cleared for use in the United States?
"Our team at Power rates the safety of Abemaciclib as a 3. This is because it is a Phase 3 trial, which means that there is some data supporting its efficacy, as well as multiple rounds of data supporting its safety."
Answered by AI
Is this research being conducted in more than one state in the U.S.?
"So far, this trial has recruited patients from Memorial Sloan Kettering Cancer Center in New york, New York, Washington University School of Medicine in Saint Louis, Missouri, and Massachusetts General Hospital Cancer Center in Boston, Massachusetts. There are 8 other locations where recruitment is still taking place."
Answered by AI
What is the most popular reason Abemaciclib is prescribed?
"Abemaciclib is an effective medication for patients with high risk of recurrence, advanced hr + her2 - breast cancer, and endocrine therapy."
Answered by AI
Are patients needed for this research project?
"The study, which was posted on 2021-11-11 and updated on 2022-10-06, is actively looking for patients to enrol."
Answered by AI
How many individuals have signed up to participate in this research project?
"One hundred and eight patients that fit the bill are required for this clinical trial. Those interested can go to Memorial Sloan Kettering Cancer Center in New york or Washington University School of Medicine in Saint Louis."
Answered by AI
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