What side effects are associated with this type of intervention?

Common treatments for Soft Tissue Sarcoma (STS) include CDK4/6 inhibitors like Abemaciclib and anthracycline-based chemotherapy regimens such as doxorubicin. CDK4/6 inhibitors can cause side effects like diarrhea, neutropenia, fatigue, and nausea. Anthracycline-based regimens, on the other hand, are associated with myelosuppression, cardiotoxicity, alopecia, mucositis, and gastrointestinal disturbances. Patients undergoing these treatments should be closely monitored for these adverse effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Soft Tissue Sarcoma (STS). Notably, CDK4/6 inhibitors like Abemaciclib are still investigational for STS, with early phase trials showing modest benefits. Other approved treatments include anthracycline-based regimens such as doxorubicin, which is commonly used as a first-line treatment. Additionally, drugs like trabectedin and eribulin have been approved for specific subtypes of STS, such as liposarcoma and leiomyosarcoma. Pazopanib, a tyrosine kinase inhibitor, is also approved for advanced STS, excluding liposarcoma and GIST. These treatments highlight the diverse therapeutic approaches available for managing STS.

What other types of research exist?

Promising novel alternatives to Abemaciclib for Soft Tissue Sarcoma patients include investigational agents such as regorafenib, cabozantinib, sorafenib, and lenvatinib plus etoposide and ifosfamide. Additionally, pazopanib has shown activity in advanced STS and may be considered as a treatment option.

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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

Must not have

Subjects must not have current evidence of another malignancy that requires treatment.

Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Abemaciclib, a cancer medication taken by mouth, in patients with advanced soft tissue and bone sarcomas. The drug works by blocking proteins that help cancer cells grow and divide.

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.

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.

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 below

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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).

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My cancer has spread and cannot be removed with surgery.

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I am 18 years old or older.

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It's been over 2 weeks since my surgery and my wounds are healing well.

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My cancer has specific gene changes related to cell growth.

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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.

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 other cancer that needs treatment.

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I have been treated with a CDK 4/6 inhibitor like palbociclib.

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I have not received any live virus vaccines in the last 30 days and will not receive any during the trial.

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I am currently on medication that strongly affects liver enzyme levels.

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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 do not have any serious ongoing illnesses that would interfere with the study.

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I have been diagnosed with a specific type of liposarcoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Death

Progression-free survival

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

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: 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

~1890

0 / 17Eligibility 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 Soft Tissue Sarcoma (STS) include CDK4/6 inhibitors, chemotherapy, and immunotherapy. CDK4/6 inhibitors, such as Abemaciclib, work by blocking the activity of cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression. This inhibition prevents cancer cells from proliferating, thereby slowing tumor growth. Chemotherapy, using agents like doxorubicin and ifosfamide, targets rapidly dividing cells, causing DNA damage and cell death. Immunotherapy, including checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells. These treatments are vital for STS patients as they offer multiple strategies to control tumor growth and improve survival outcomes.

Recent advances of highly selective CDK4/6 inhibitors in breast cancer.Trabectedin and olaparib in patients with advanced and non-resectable bone and soft-tissue sarcomas (TOMAS): an open-label, phase 1b study from the Italian Sarcoma Group.