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CDK4/6 Inhibitor
Abemaciclib for Sarcoma
Phase 2
Recruiting
Led By John Charlson, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Cyclin Dependent Kinase Inhibitor 2A (CDKN2A) or CDKN2B copy number loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will enroll 45 subjects with metastatic or unresectable soft tissue sarcoma or bone sarcoma. All subjects will receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met.
Who is the study for?
Adults with certain types of advanced sarcomas (like osteosarcoma, chondrosarcoma) that can't be surgically removed and have specific CDK pathway changes. They should not have had prior treatment with CDK4/6 inhibitors, must show disease progression recently or be newly diagnosed, and their organs must function well. Women of childbearing potential need to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Abemaciclib, given orally at a dose of 200 mg twice daily to see if it's effective for patients with bone and soft tissue sarcomas that have alterations in the CDK pathway. It's a phase II study where all participants receive the same treatment until they no longer benefit from it.See study design
What are the potential side effects?
Abemaciclib may cause fatigue, diarrhea, low blood cell counts which can lead to infections or bleeding problems, liver issues reflected by altered blood tests, deep vein thrombosis or pulmonary embolism (blood clots), and possible harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has a specific genetic change (loss of CDKN2A or CDKN2B).
Select...
My cancer has spread and cannot be removed with surgery.
Select...
I am 18 years old or older.
Select...
It's been over 2 weeks since my surgery and my wounds are healing well.
Select...
My cancer has specific gene changes related to cell growth.
Select...
My kidney function is within the required range.
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I have had surgery to remove my uterus and/or both ovaries.
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I have been diagnosed with a specific type of bone or soft tissue cancer.
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My cancer is Rb positive based on a specific test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Death
Progression-free survival
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
1Treatment groups
Experimental Treatment
Group I: AbemaciclibExperimental Treatment1 Intervention
Subjects will be treated with abemaciclib 200 mg twice daily by mouth.
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?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,669 Total Patients Enrolled
John Charlson, MDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
University Of Iowa College Of Medicine (Medical School)
Medical College Wi Affil Hosps, Inc (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.It has been more than 14 days since my last radiotherapy session.I have recovered from my last chemotherapy, except for possible hair loss or mild nerve pain.I have Gilbert's syndrome but my total bilirubin is not more than twice the upper limit and my direct bilirubin is normal.I do not have any other cancer that needs treatment.I have been postmenopausal for at least one year.My cancer has a specific genetic change (loss of CDKN2A or CDKN2B).I have had anthracycline chemotherapy for my bone cancer.My cancer has spread and cannot be removed with surgery.It has been over 21 days since my last chemotherapy session.I am a male and agree to follow the birth control requirements.I can start treatment the day after receiving a blood transfusion to increase my hemoglobin.I am a woman who is not pregnant, not breastfeeding, and not able to become pregnant.My cancer has a CDK pathway abnormality found in genetic testing.I am 18 years old or older.I have been treated with a CDK 4/6 inhibitor like palbociclib.I have not received any live virus vaccines in the last 30 days and will not receive any during the trial.My cancer has worsened or was diagnosed in the last 6 months.It's been over 2 weeks since my surgery and my wounds are healing well.I am currently on medication that strongly affects liver enzyme levels.I can take pills by mouth.I have a history of serious heart conditions, including fainting due to heart issues, dangerous irregular heartbeats, or sudden cardiac arrest.I do not have any serious ongoing illnesses that would interfere with the study.I agree to practice true abstinence as a form of contraception.My cancer has specific gene changes related to cell growth.I may have had multiple treatments, but I meet specific requirements.My kidney function is within the required range.I have had at least one treatment for my soft tissue sarcoma, unless it's a type usually not treated with chemotherapy.I have had surgery to remove my uterus and/or both ovaries.I have been diagnosed with a specific type of bone or soft tissue cancer.My organ and bone marrow functions are within normal limits.I have been diagnosed with a specific type of liposarcoma.My cancer is Rb positive based on a specific test.I agree to practice true abstinence as a form of contraception.You are currently taking any experimental medications for other studies.My brain metastasis was treated and has been stable for 3 months.My condition does not require previous treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Abemaciclib have a lot of research backing it?
"The first clinical trial for abemaciclib was in 2009. If you would like more information about the locations of these trials, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) or speak with your personal physician. 97 studies are recruiting patients right now, with many of them based out of Iowa City, Iowa."
Answered by AI
Are we still looking for patients to participate in this experiment?
"The clinical trial mentioned is still recruiting patients, with the latest update being on 4/4/2022. The study was initially posted 10/7/2019"
Answered by AI
What makes this particular trial unique?
"Abemaciclib's clinical trials started in 2009 with Eli Lilly and Company as the primary sponsor. The first study only involved 220 people but it was enough to get Phase 1 drug approval. Now, there are 97 active studies being conducted in 1275 cities across 41 different countries."
Answered by AI
How many people are involved in this research project?
"That is correct. The information available on clinicaltrials.gov says that the trial is currently looking for 45 patients from 4 different sites. The trial was first posted on October 7th, 2019 and most recently updated on April 4th, 2022."
Answered by AI
Are there a lot of facilities conducting this research in Canada?
"So far, this clinical trial has recruited patients from the following hospitals: University of Iowa Hospitals and Clinics in Iowa City, Iowa; Washington University in St. Louis in Saint Louis, Missouri; Froedtert Hospital & the Medical College of Wisconsin in Milwaukee, Wisconsin; as well as 4 other locations."
Answered by AI
Does Abemaciclib put patients at risk for any adverse health effects?
"Abemaciclib's safety level was estimated to be a 2. This is because, while there is some data supporting safety, there is none that speaks to the efficacy of the medication."
Answered by AI
What is the primary indication for Abemaciclib?
"Abemaciclib is most often used as a preventative measure for high-risk patients that are likely to experience cancer recurrence. It can also be used to treat more aggressive forms of breast cancer that are hormone receptor positive and human epidermal growth factor 2 negative."
Answered by AI
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