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Cyclin-Dependent Kinase Inhibitor
Abemaciclib + Fulvestrant for Endometrial Cancer
Phase 2
Waitlist Available
Led By Angela Green, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior bilateral oophorectomy
History of hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new drug combo to see if it's more effective than current treatments for this type of cancer, and what kind of side effects it causes.
Who is the study for?
This trial is for women over 18 with recurrent endometrial cancer who've had a hysterectomy and/or oophorectomy, are postmenopausal, and may have had limited prior treatments. They should be in good health otherwise, not pregnant or breastfeeding, willing to use contraception if of childbearing potential, and able to swallow pills.Check my eligibility
What is being tested?
The study tests the effectiveness of combining two drugs: Abemaciclib and Fulvestrant in treating recurrent endometrial cancer. It also examines the side effects of this treatment combination on participants.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include nausea, fatigue, risk of infection due to low blood cell counts, hot flashes from hormonal therapy like fulvestrant and possible liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had both of my ovaries surgically removed.
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I have had a hysterectomy.
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I have received chemotherapy with radiation to enhance its effect.
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I am 18 years old or older.
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My endometrial cancer has come back or hasn't responded to treatment.
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My endometrial cancer is mostly made up of endometrioid cells.
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I have fully recovered from radiotherapy and it has been at least 14 days since my last session.
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My cancer is one of the specified types of epithelial cell cancer.
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I am fully active or able to carry out light work, with a high level of self-care.
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I am very active and can carry out all my daily activities without help.
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I am 60 years old or older.
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I am postmenopausal due to surgery or naturally.
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My endometrial cancer is hormone receptor positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
objective response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fulvestrant in Combination with AbemaciclibExperimental Treatment2 Interventions
Eligible patients will take Abemaciclib 150 milligrams mg orally once every 12 hours on days 1-28. Fulvestrant will be dosed 500mg intramuscularly (IM) on days 1 and 15 during cycle 1 and then on Day 1 during subsequent cycles. Each cycle will be 28 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,827 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,480 Patients Enrolled for Endometrial Cancer
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,532 Total Patients Enrolled
11 Trials studying Endometrial Cancer
1,062 Patients Enrolled for Endometrial Cancer
Angela Green, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had both of my ovaries surgically removed.You have given permission for your personal information to be shared and have signed a document saying you understand the study.I have had a hysterectomy.I have received chemotherapy with radiation to enhance its effect.My side effects from recent cancer treatments are mild, except for nerve issues or hair loss.I have been treated with specific cancer drugs like fulvestrant or CDK4/6 inhibitors.I am HIV positive.My recent blood and organ function tests are within normal ranges.I have a significant history of liver problems or currently abuse alcohol.It is preferred that your disease recurrence or progression has been confirmed through biopsies or cell tests, but it is not mandatory.I am 18 years old or older.You have participated in another clinical trial or medical research within the last 30 days, or you are currently enrolled in another research study that is not compatible with this study.My autoimmune disease isn't controlled by basic anti-inflammatory medication.I started treatment with bone-strengthening drugs less than a week ago.If the doctor thinks there is another health problem that makes it unsafe for you to take part in the study, you will not be able to participate.You cannot or do not want to swallow pills.I have not had a heart attack or severe heart issues in the last 6 months.I have moderate to severe heart failure.I have a condition that affects how my body absorbs food.I may have had up to two chemotherapy treatments for endometrial cancer.I may have had one type of hormone therapy for my cancer, but no more than that.My side effects from recent cancer treatments are mild, except for nerve issues or hair loss.My cancer has spread to the lining of my brain and spinal cord.I can swallow pills.I am not pregnant and agree to use birth control during and for 1 month after the study.I do not have any infections needing antibiotics, except for a simple UTI.I stopped any hormone treatments for my cancer 2 weeks before starting the study.My endometrial cancer has come back or hasn't responded to treatment.My endometrial cancer is mostly made up of endometrioid cells.I stopped all cancer treatments, including immunotherapy and radiation, at least 21 days ago.I have recovered from chemotherapy side effects, except for hair loss or mild nerve pain.I have fully recovered from radiotherapy and it has been at least 14 days since my last session.My cancer has spread to my internal organs, causing a crisis.I have had a stem-cell transplant.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I do not have any severe illnesses that are not under control.My cancer is one of the specified types of epithelial cell cancer.I am fully active or able to carry out light work, with a high level of self-care.I have untreated brain metastases.I am very active and can carry out all my daily activities without help.My chemotherapy was part of my radiation treatment to make it more effective.I have had only one hormone treatment for my cancer.I have had up to two chemotherapy treatments for endometrial cancer.My tumor in the previously treated area has grown or been confirmed by biopsy after radiation.I am 60 years old or older.I am postmenopausal due to surgery or naturally.My endometrial cancer is hormone receptor positive.
Research Study Groups:
This trial has the following groups:- Group 1: Fulvestrant in Combination with 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 this experiment in need of additional participants?
"Clinicaltrials.gov shows that this experiment is still recruiting subjects; it was first made available on August 21st 2018 and has most recently been updated on October 12th 2022."
Answered by AI
Can you elucidate the dangers of administering Fulvestrant to individuals?
"The safety of fulvestrant was judged to be a 2 on our team's scale, given that this is a Phase 2 trial and there are data confirming its security but not its effectiveness."
Answered by AI
What other investigations have been conducted regarding Fulvestrant's efficacy?
"Since its inauguration at Lowell General Hospital in 2004, 119 studies have been conducted on fulvestrant. Today, 204 trials are actively enrolling patients; many of these taking place in Uniondale, New jersey."
Answered by AI
What is the aggregate number of individuals participating in this research?
"Affirmative. According to the data on clinicaltrials.gov, this research protocol is actively accepting participants and has been since August 21st 2018 when it was first posted online. This trial, which was last amended October 12th 2022, requires 25 patients across 7 sites for successful completion."
Answered by AI
In what scenarios is Fulvestrant typically administered?
"Fulvestrant is an effective therapy for pik3ca gene mutation and advanced hr + her2 - breast cancer, malignant neoplasms, and progression of the disease."
Answered by AI
Are there a multitude of sites administering this experiment across the United States?
"For those interested in participating, there are 7 medical centres that can provide treatment. These include Memorial Sloan Kettering Nassau (Uniondale), Memorial Sloan Kettering Cancer Center (New york City) and Memoral Sloan Kettering Monmouth (Middletown)."
Answered by AI
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