What is the mechanism of action of this treatment?

The most common treatments for Liposarcoma include CDK4/6 inhibitors like Abemaciclib, which block cyclin-dependent kinases 4 and 6 to prevent cancer cell proliferation. Chemotherapy agents such as doxorubicin work by causing DNA damage and inducing apoptosis. Targeted therapies like mTOR inhibitors (e.g., sirolimus) inhibit the mTOR pathway, reducing cell growth and proliferation. Understanding these mechanisms helps in tailoring treatment strategies to the tumor's molecular profile, potentially improving outcomes for Liposarcoma patients.

What side effects are associated with this type of intervention?

Common treatments for liposarcoma include chemotherapy agents like doxorubicin and ifosfamide, as well as targeted therapies such as CDK4/6 inhibitors like Abemaciclib. The side effects of Abemaciclib, a CDK4/6 inhibitor, typically include diarrhea, neutropenia, fatigue, nausea, and abdominal pain. Other chemotherapy agents like doxorubicin and ifosfamide can cause side effects such as myelosuppression, cardiotoxicity, nausea, vomiting, and alopecia. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for liposarcoma, including the CDK4/6 inhibitor palbociclib, which has shown efficacy in certain subtypes of liposarcoma. Other approved treatments include eribulin and trabectedin, which are used for advanced or metastatic liposarcoma. These drugs work through different mechanisms, such as microtubule inhibition and DNA binding, respectively, but are part of the broader landscape of chemotherapeutic and targeted therapies for liposarcoma.

What other types of research exist?

Promising alternatives to Abemaciclib for Liposarcoma patients include mTOR inhibitors like sirolimus, which have shown clinical activity in malignant perivascular epithelioid cell tumors, and targeted therapies identified through next-generation sequencing that may reveal actionable mutations. Additionally, ongoing trials and studies involving novel agents such as immunotherapies (e.g., pembrolizumab) and other targeted therapies (e.g., tyrosine kinase inhibitors) could offer new treatment options.

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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.

Must not have

Patients that have GI absorption disorders that would impact the administration of oral abemaciclib.

The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing abemaciclib, a drug that blocks proteins helping cancer cells grow, in patients with advanced or spreading DDLS. The goal is to see if it can stop the cancer from getting worse.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any stomach or intestine problems that affect how I absorb pills.

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I have a history of serious heart conditions, including fainting due to heart issues, dangerous irregular heartbeats, or sudden cardiac arrest.

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I have a brain condition that hasn't been treated yet.

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I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.

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My cancer can potentially be cured by surgery.

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I haven't had major surgery in the last 3 weeks or have fully recovered from recent surgery.

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I am not pregnant or nursing.

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I have previously been treated with drugs like abemaciclib or palbociclib.

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I have not had any other cancers within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the progression-free survival of patients treated with abemaciclib versus placebo

Secondary study objectives

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 • 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

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1890

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Liposarcoma include CDK4/6 inhibitors like Abemaciclib, which block cyclin-dependent kinases 4 and 6 to prevent cancer cell proliferation. Chemotherapy agents such as doxorubicin work by causing DNA damage and inducing apoptosis. Targeted therapies like mTOR inhibitors (e.g., sirolimus) inhibit the mTOR pathway, reducing cell growth and proliferation. Understanding these mechanisms helps in tailoring treatment strategies to the tumor's molecular profile, potentially improving outcomes for Liposarcoma patients.

The role of abemaciclib in treatment of advanced breast cancer.