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CDK4/6 Inhibitor
Abemaciclib + Letrozole for Endometrial Cancer
Phase 2
Waitlist Available
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have endometrioid histology (all grades allowed) based on hysterectomy or biopsy specimen (Hormone receptor status is not required for enrollment).
Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy. Histologic confirmation of recurrent disease is required. For cases of persistent disease, histologic confirmation of the primary disease with radiologic evidence of progression is required.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it stops the disease from progressing in women with endometrioid endometrial cancer. Treatment will continue until the patient experiences side effects, the disease progresses, or they request to stop.
Who is the study for?
This trial is for adults with advanced, persistent, or recurrent endometrioid endometrial cancer that can't be cured by surgery or radiotherapy. Participants must have measurable disease, no more than two prior systemic therapies (only one may include chemo), and good organ function. They cannot join if they've had CDK4/6 inhibitors before, other cancer types like clear cell or serous cancers, known allergies to the drugs being tested, active infections, CNS metastases, HIV infection, certain medical conditions affecting drug absorption or bleeding risk.Check my eligibility
What is being tested?
The trial tests how well patients with specific endometrial cancer respond to a combination of Abemaciclib and Letrozole after six months without their disease getting worse. It's a phase II study where all participants receive the same treatment until it's not tolerated anymore or until the disease progresses.See study design
What are the potential side effects?
Possible side effects from Abemaciclib and Letrozole could include fatigue, diarrhea, nausea and vomiting; low blood counts leading to increased infection risk; liver problems; deep vein thrombosis; pulmonary embolism; hair loss; headache; joint pain and osteoporosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is endometrioid type, confirmed by surgery or biopsy.
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My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.
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I have a tumor or lymph node that can be measured and meets the size requirements.
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My organs and bone marrow are working well.
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My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.
Select...
I am 18 years old or older.
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I've recovered from previous cancer treatments, except for possible hair loss or mild nerve damage.
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I am not pregnant and use effective birth control.
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I've had only one chemotherapy and one other cancer treatment.
Select...
I can take pills by mouth.
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I can carry out all my daily activities without help.
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I have fully recovered from my radiotherapy treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 weeks assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Response rate
Time to disease progression or death
Toxicity Assessment of Adverse Events
Other outcome measures
Cyclin D1 3'UTR mutations
Estradiol levels
Insulin levels
+3 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: Abemaciclib and LetrozoleExperimental Treatment2 Interventions
Study treatment will consist of abemaciclib 150mg orally twice a day and letrozole 2.5mg orally once a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3240
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,873 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,282 Patients Enrolled for Endometrial Cancer
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,876 Total Patients Enrolled
9 Trials studying Endometrial Cancer
933 Patients Enrolled for Endometrial Cancer
Marilyn Huang, MDStudy ChairUniversity of Virginia
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication that targets CDK4/6 for my cancer.My cancer has spread to my brain.I do not have any ongoing serious infections.I do not have serious health issues that would stop me from joining.I've had chemotherapy for early-stage cancer or for a pelvic recurrence.My cancer's MMR, MSI, and hormone receptor status have been tested and reported if available.My cancer is endometrioid type, confirmed by surgery or biopsy.My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.I have at least one measurable tumor to track treatment progress.I have a tumor or lymph node that can be measured and meets the size requirements.I have had at most one chemotherapy and one other type of systemic therapy.You are pregnant or currently breastfeeding a baby.I can provide results of my MMR, MSI, and hormone receptor tests if they were done.I had chemotherapy for stage IV cancer, am now cancer-free, and it's been 6+ months since my treatment ended.I am on long-term steroids or other drugs that weaken my immune system.My organs and bone marrow are working well.You cannot have participated in another clinical trial with an experimental drug within 30 days before this study.I plan to get a live vaccine within a week of starting abemaciclib or during the study.My cancer is of the endometrioid type.My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.I am 18 years old or older.I've recovered from previous cancer treatments, except for possible hair loss or mild nerve damage.I am not pregnant and use effective birth control.I have had hormonal therapy for endometrial cancer.I have had chemotherapy for early-stage cancer.I am currently experiencing active bleeding or am at high risk for bleeding.I've had only one chemotherapy and one other cancer treatment.I have recovered from the side effects of my last cancer treatment.I can take pills by mouth.I can carry out all my daily activities without help.I am allergic or have had a bad reaction to abemaciclib or letrozole.My cancer is one of the specified types affecting the uterus.I am HIV positive.I have had blood clots without a clear cause but am on blood thinners.I have a digestive condition that affects how my body absorbs medication.I have had chemoradiotherapy for a pelvic recurrence.I have previously received immunotherapy or targeted therapy.I have fully recovered from my radiotherapy treatments.I have had immunotherapy or targeted therapy for my condition.I have not had any other cancer besides this one in the last 5 years.I have a known history of heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib and Letrozole
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.
Endometrial Cancer Patient Testimony for trial: Trial Name: NCT04393285 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary indications for Abemaciclib?
"Abemaciclib is most commonly used as an intervention for breast cancer. However, it can also be prescribed to treat conditions such as anovulatory cycles and tamoxifen resistance."
Answered by AI
How many people can sign up for this research project?
"This study is not actively recruiting patients at the moment, as seen by its posting date of October 10th, 2020 and most recent edit on September 1st, 2022. However, there are 294 other trials for endometrial cancer and 245 studies involving abemaciclib that are currently looking for participants."
Answered by AI
Why was this clinical trial created?
"This study's primary outcome is progression-free survival, and will be assessed over a period of 5 years. Secondary outcomes include response rate, toxicity assessment of adverse events, and time to disease progression or death."
Answered by AI
Are people still being accepted into this trial program?
"No, this particular study is not actively recruiting at the moment. The trial was first posted on October 10th 2020 and updated September 1st 2022 according to clinicaltrials.gov. There are 539 other trials searching for patients though."
Answered by AI
How many total sites are participating in this clinical trial?
"Currently, patients can enroll at Smillow Cancer Care at Greenwich Hospital in Greenwich, Connecticut; University of Chicago in Chicago, Illinois; Smillow Cancer Care at Greenwich in Miami, Florida and 32 other locations."
Answered by AI
What does the scientific research community know about Abemaciclib?
"Currently, there are 245 ongoing trials studying Abemaciclib with 55 trials in Phase 3. While several of the studies for Abemaciclib are based in San Francisco, California, there are 16776 locations operating studies for Abemaciclib."
Answered by AI
Do Abemaciclib's benefits outweigh its risks for human patients?
"Abemaciclib's safety is rated as a 2 because, while there is evidence that it is not harmful, there is no data currently supporting that it is an effective treatment."
Answered by AI
Who else is applying?
What site did they apply to?
Tufts Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Previous treatment has been helpful to limit the tumor growth. However, the tumor markers have been recently increasing rapidly.
PatientReceived no prior treatments
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