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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
Must not have
Patients who have not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1
Patients who have received prior treatment with a selective CDK4 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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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.
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My cancer has spread and cannot be removed with surgery.
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My organs and bone marrow are working well.
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I do not have any other cancer that needs treatment.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have recovered from previous treatment side effects to a mild level.
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I have been treated with a CDK4 inhibitor before.
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I do not have any severe illnesses or infections that would interfere with the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
progression-free

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%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,679 Previous Clinical Trials
3,465,720 Total Patients Enrolled
19 Trials studying Sarcoma
1,715 Patients Enrolled for Sarcoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,467 Total Patients Enrolled
70 Trials studying Sarcoma
13,798 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

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02846987 — Phase 2
Sarcoma Research Study Groups: Abemaciclib (LY2835219)
Sarcoma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02846987 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02846987 — Phase 2
~2 spots leftby Jul 2025
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