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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who are progression-free
Secondary outcome measures
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%
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: 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
~1710
Anastrozole
2019
Completed Phase 4
~10300
Letrozole
2002
Completed Phase 4
~2770

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
27,912 Total Patients Enrolled
6 Trials studying Ovarian Cancer
212 Patients Enrolled for Ovarian Cancer
Eli Lilly and CompanyIndustry Sponsor
2,627 Previous Clinical Trials
3,217,771 Total Patients Enrolled
22 Trials studying Ovarian Cancer
1,783 Patients Enrolled for Ovarian Cancer
Gottfried E KonecnyPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04469764 — Phase 2
Ovarian Cancer Research Study Groups: Treatment (abemaciclib)
Ovarian Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04469764 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469764 — Phase 2
~7 spots leftby Jul 2025
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