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CDK4/6 Inhibitor

Abemaciclib for Recurrent Ovarian or Endometrial Cancer

Phase 2

Recruiting

Led By Gottfried E Konecny

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Molecular tumor board confirms that patient's archival ovarian cancer tumor specimen has been assessed using standard of care genomic profiling and demonstrates CDK4/6 activation features

Molecular tumor board confirms that patient's archival endometrial cancer tumor specimen has been assessed using standard of care genomic profiling and is of endometrioid histology, has positive hormone receptor expression and lack of Cyclin E gene (CCNE) amplification or retinoblastoma susceptibility gene product (RB) loss

Must not have

Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal intrauterine device (IUD), condoms, sexual abstinence or vasectomized partner

Unstable brain metastases or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well abemaciclib works in treating patients with ovarian or endometrial cancer that has come back. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for patients with recurrent ovarian or endometrial cancer that has shown CDK4/6 pathway activation. Participants must have had at least one prior chemotherapy regimen, be able to swallow pills, and meet specific blood count criteria. They should not have other recent cancers or major health issues like unstable heart disease, infections requiring IV antibiotics, or certain mental conditions.

What is being tested?

The effectiveness of abemaciclib in treating recurrent ovarian and endometrial cancer is being tested. This drug aims to halt tumor growth by inhibiting enzymes necessary for cell proliferation. The study will determine if abemaciclib improves treatment outcomes for these cancers.

What are the potential side effects?

Abemaciclib may cause side effects such as diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, abdominal pain, and possibly hair loss. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ovarian cancer has been tested and shows CDK4/6 activation.

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My endometrial cancer is hormone receptor positive and lacks certain genetic changes.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer.

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I have had chemotherapy before for my ovarian or endometrial cancer.

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I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.

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I can take pills by mouth.

Exclusion Criteria

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

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I am not willing to use effective birth control methods.

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I do not have unstable brain tumors or cancer in the lining of my brain.

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I do not have severe lung problems, major stomach surgery, Crohn's, ulcerative colitis, or chronic severe diarrhea.

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I do not expect to need major surgery or radiation therapy during the trial.

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I am not pregnant, breastfeeding, and have been menopausal for over 6 months or am surgically sterile.

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I am not using, nor do I plan to use, strong CYP3A4 inhibitors like grapefruit juice or certain medications.

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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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I have a history of serious heart rhythm problems or sudden cardiac arrest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients who are progression-free

Secondary study objectives

Clinical benefit rate

Incidence of adverse events

Objective response rate (ORR)

+1 more

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: Treatment (abemaciclib)Experimental Treatment3 Interventions

Patients receive abemaciclib PO BID on days 1-28. Patients with tumors that are hormone receptor positive also receive and anastrozole or letrozole per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Anastrozole

2016

Completed Phase 4

~5550