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CDK4/6 Inhibitor
Abemaciclib for Liposarcoma
Phase 2
Waitlist Available
Led By Mark Dickson, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0 or 1
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Women must not breastfeed while on study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing the effects of the drug Abemaciclib on cancer growth. Researchers hope to learn if the drug can delay cancer growth or shrink tumors. Abemaciclib is not FDA approved, but has shown promise in shrinking tumors in patients with breast cancer, lymphoma, and lung cancer.
Who is the study for?
This trial is for adults with a specific cancer called dedifferentiated liposarcoma, confirmed at MSKCC. Participants must have measurable disease progression recently and can have had any number of prior treatments, but not within the last 2-4 weeks (6 weeks for certain drugs). They should be in good physical condition (ECOG 0 or 1), not have other active cancers, and agree to use contraception. Those with stable treated brain metastasis may join.Check my eligibility
What is being tested?
The study is testing Abemaciclib's effects on dedifferentiated liposarcoma. The drug has shown promise in shrinking tumors in breast cancer, lymphoma, and lung cancer patients but isn't FDA approved for liposarcoma yet. Researchers want to see if it can delay tumor growth or shrink tumors by at least one quarter.See study design
What are the potential side effects?
Abemaciclib could potentially cause side effects as it works against cancer cells. While specifics aren't provided here, common side effects from similar medications include nausea, diarrhea, low blood cell counts increasing infection risk, fatigue, liver issues and potential 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 can carry out light work.
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I agree to use birth control and will not breastfeed while in the study.
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My dedifferentiated liposarcoma was confirmed at MSKCC.
Select...
My cancer has spread and cannot be removed with surgery.
Select...
My organs and bone marrow are working well.
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I do not have any other cancer that needs treatment.
Select...
I am 18 years old or older.
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
progression-free
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: Abemaciclib (LY2835219)Experimental Treatment1 Intervention
Patients will be treated with abemaciclib 200 mg bid.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,896 Total Patients Enrolled
17 Trials studying Sarcoma
1,650 Patients Enrolled for Sarcoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,587 Total Patients Enrolled
70 Trials studying Sarcoma
13,734 Patients Enrolled for Sarcoma
Mark Dickson, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Sarcoma
90 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain metastasis was treated and has been stable for 3 months.I am fully active or can carry out light work.I agree to use birth control and will not breastfeed while in the study.I have recovered from previous treatment side effects to a mild level.I have been treated with a CDK4 inhibitor before.My dedifferentiated liposarcoma was confirmed at MSKCC.My cancer has spread and cannot be removed with surgery.My cancer can be measured and has worsened in the last 6 months.My organs and bone marrow are working well.I have not had any cancer treatment in the last 2-4 weeks.I do not have any other cancer that needs treatment.I do not have any severe illnesses or infections that would interfere with the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib (LY2835219)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
For what conditions is Abemaciclib typically prescribed?
"Abemaciclib is a common treatment choice for high risk of recurrence and can be beneficial to those suffering from advanced hr + her2 - breast cancer, endocrine therapy-resistant disease, and other forms of breast malignancy."
Answered by AI
Is this pioneering research the inaugural of its kind?
"Abemaciclib was initially studied in 2009, and Eli Lilly sponsored the first clinical trial involving 220 participants. After receiving Phase 1 drug approval, numerous further trials were initiated across 41 nations within 1276 cities; 92 of these studies are still ongoing."
Answered by AI
Could you elaborate on the potential risks associated with Abemaciclib?
"The safety of Abemaciclib is rated as a 2 on our scale, given that the clinical trial has only reached Phase 2 and thus there is evidence to suggest it may be safe but no data supporting its efficacy."
Answered by AI
What is the current enrollment status of this investigation?
"This clinical trial is no longer accepting participants. The original posting was on July 1st 2016, and the last update was registered August 17th 2022. Alternatives are available; there are presently 463 trials enrolling patients with sarcoma and 92 studies recruiting individuals for Abemaciclib treatment."
Answered by AI
How many patients are participating in this clinical investigation?
"This trial has concluded its recruitment period, which began on July 1st 2016 and ended August 17th 2022. If you are interested in joining other medical trials investigating sarcoma or Abemaciclib, there are currently 463 and 92 studies respectively that remain open for enrollment."
Answered by AI
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