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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.
Must not have
Previously received any CDK4/6 inhibitor
Known central nervous system metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks assessed up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Select...
My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.
Select...
I have a tumor or lymph node that can be measured and meets the size requirements.
Select...
My organs and bone marrow are working well.
Select...
My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.
Select...
I am 18 years old or older.
Select...
I've recovered from previous cancer treatments, except for possible hair loss or mild nerve damage.
Select...
I am not pregnant and use effective birth control.
Select...
I've had only one chemotherapy and one other cancer treatment.
Select...
I can take pills by mouth.
Select...
I can carry out all my daily activities without help.
Select...
I have fully recovered from my radiotherapy treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have taken medication that targets CDK4/6 for my cancer.
Select...
My cancer has spread to my brain.
Select...
I do not have any ongoing serious infections.
Select...
I do not have serious health issues that would stop me from joining.
Select...
I am on long-term steroids or other drugs that weaken my immune system.
Select...
I have had hormonal therapy for endometrial cancer.
Select...
I am currently experiencing active bleeding or am at high risk for bleeding.
Select...
I am allergic or have had a bad reaction to abemaciclib or letrozole.
Select...
My cancer is one of the specified types affecting the uterus.
Select...
I am HIV positive.
Select...
I have had blood clots without a clear cause but am on blood thinners.
Select...
I have a digestive condition that affects how my body absorbs medication.
Select...
I have not had any other cancer besides this one in the last 5 years.
Select...
I have a known history of heart disease.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival
Secondary study objectives
Response rate
Time to disease progression or death
Toxicity Assessment of Adverse Events
Other study objectives
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%
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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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
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: 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
~3590
Abemaciclib
2019
Completed Phase 2
~1890
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
65,128 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,282 Patients Enrolled for Endometrial Cancer
Eli Lilly and CompanyIndustry Sponsor
2,671 Previous Clinical Trials
3,228,969 Total Patients Enrolled
10 Trials studying Endometrial Cancer
1,079 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
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