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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
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 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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
~3240
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,680 Total Patients Enrolled
6 Trials studying Ovarian Cancer
212 Patients Enrolled for Ovarian Cancer
Eli Lilly and CompanyIndustry Sponsor
2,619 Previous Clinical Trials
3,206,567 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ovarian cancer has been tested and shows CDK4/6 activation.I am not willing to use effective birth control methods.I do not have unstable brain tumors or cancer in the lining of my brain.My hemoglobin level is at least 8 g/dL, possibly after a blood transfusion.My endometrial cancer is hormone receptor positive and lacks certain genetic changes.I do not expect to need major surgery or radiation therapy during the trial.I do not have severe lung problems, major stomach surgery, Crohn's, ulcerative colitis, or chronic severe diarrhea.I have recovered from chemotherapy side effects, except for hair loss or mild nerve pain.I can take care of myself and am up and about more than half of my waking hours.You have a serious medical or mental health condition, or abnormal lab results that could put you at risk or make it difficult to participate in the trial.I am not pregnant, breastfeeding, and have been menopausal for over 6 months or am surgically sterile.I am not pregnant and agree to use effective birth control during and 3 weeks after treatment.I am not using, nor do I plan to use, strong CYP3A4 inhibitors like grapefruit juice or certain medications.I haven't had any cancer except for certain skin cancers or localized cervical or breast cancer in the last 5 years.I haven't had chemotherapy, surgery, blood transfusions, or experimental treatments in the last 3 weeks.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.I have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer.I have had chemotherapy before for my ovarian or endometrial cancer.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I can take pills by mouth.I haven't had a heart attack, severe chest pain, major heart surgery, stroke, or blood clots in the last 6 months.I have a history of serious heart rhythm problems or sudden cardiac arrest.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (abemaciclib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial still open?
"Affirmative. Data on clinicaltrials.gov confirms that this medical study, which was originally posted October 16th 2020, is actively recruiting for 32 patients at 1 site location."
Answered by AI
Is there a precedent of Abemaciclib being explored for clinical research?
"Presently, 250 clinical trials are being conducted with Abemaciclib. Of these ongoing studies, 55 have entered Phase 3 of development. Although the majority of experiments for this medication take place in San Francisco, California, there are 16683 medical sites participating globally."
Answered by AI
Has Abemaciclib achieved the necessary regulatory authorization?
"Based on our evaluation, Abemaciclib is rated as a 2 in terms of safety. This score is reflective of the fact that there are some data points indicating its security, however no clinical trials have yet been conducted to support efficacy claims."
Answered by AI
What conditions can Abemaciclib be utilized to treat?
"Abemaciclib is prescribed as a post-tamoxifen therapy that can last between two and three years. This medication also has potential to improve outcomes in cases of tamoxifen, invasive early breast cancer, and patients with high recurrence risk."
Answered by AI
What is the ceiling of participants in this clinical trial?
"Affirmative. Based on the information posted to clinicaltrials.gov, this medical trial is currently open for recruitment and began accepting applications on October 16th 2020. It requires 32 participants who can access one of its centralized sites."
Answered by AI
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