Your session is about to expire
← Back to Search
CDK4/6 Inhibitor
Abemaciclib + Letrozole +/- Metformin for Endometrial Cancer
Phase 2
Recruiting
Led By Panagiotis Konstantininopoulos, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA-certified laboratory
ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is looking at whether giving these drugs together might work better than giving letrozole alone.
Who is the study for?
This trial is for adults with measurable, estrogen-receptor positive endometrial cancer that's recurrent or resistant to standard treatments. They must have good organ and bone marrow function, no history of certain heart conditions or uncontrolled illnesses, and not be on conflicting medications. Women must use contraception and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests a combination of targeted therapies: Abemaciclib (Verzenio™), Letrozole (Femara®), with or without Metformin (Glucophage®) as potential treatments for ER+ endometrial cancer. It aims to see how well these drugs work together in treating this type of cancer.See study design
What are the potential side effects?
Potential side effects include digestive issues, blood sugar changes due to metformin; fatigue, diarrhea from abemaciclib; joint pain from letrozole; and the general risk of infection increase due to immune system impact by these therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is estrogen receptor-positive.
Select...
I am fully active or can carry out light work.
Select...
My endometrial cancer has returned, spread, or doesn’t respond to standard treatments.
Select...
My cancer is confirmed as endometrioid endometrial or carcinosarcoma with an endometrioid part.
Select...
I have a tissue sample from a previous biopsy that can be used for analysis.
Select...
I have a tumor that can be measured with scans or exams.
Select...
I can swallow and keep down pills.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Tumor Response Rate
Progression Free Survival Rate
Secondary outcome measures
Overall Survival Rate
Treatment-related toxicities
Side 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
4Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment3 Interventions
Abemaciclib is administered by mouth twice daily
Letrozole is administered by mouth once daily
Metformin is administered by mouth once daily
Group II: Cohort 2Experimental Treatment2 Interventions
Abemaciclib is administered by mouth twice daily
LY3023414 is administered by mouth twice daily
Group III: Cohort 1AExperimental Treatment2 Interventions
Abemaciclib is administered by mouth twice daily
Letrozole is administered by mouth once daily
Group IV: Cohort 1Experimental Treatment3 Interventions
Abemaciclib is administered by mouth twice daily
LY3023414 is administered by mouth twice daily
Letrozole is administered by mouth once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
LY3023414
2014
Completed Phase 2
~850
Letrozole
2002
Completed Phase 4
~3240
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,888 Total Patients Enrolled
8 Trials studying Endometrial Cancer
1,446 Patients Enrolled for Endometrial Cancer
Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,200,998 Total Patients Enrolled
10 Trials studying Endometrial Cancer
1,002 Patients Enrolled for Endometrial Cancer
Panagiotis Konstantininopoulos, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have had heart problems or treatments within the last 6 months.My cancer is estrogen receptor-positive.I am fully active or can carry out light work.I am not taking any strong medication that affects liver enzymes.I am using birth control and will continue for 3 months after treatment ends.I am not pregnant or breastfeeding if I join this trial.I had cancer before, but it's either been 5 years since I'm disease-free, or it was a non-aggressive type treated within the last 5 years.My high blood pressure is not controlled, even with medication.My endometrial cancer has returned, spread, or doesn’t respond to standard treatments.My cancer is confirmed as endometrioid endometrial or carcinosarcoma with an endometrioid part.I have a tissue sample from a previous biopsy that can be used for analysis.I do not have HIV due to the risk of severe infections with treatment.I haven't had chemotherapy, immune therapy, or major surgery in the last 4 weeks.I have a tumor that can be measured with scans or exams.I have previously been treated with CDK4/6 inhibitors.I can swallow and keep down pills.I do not have brain metastases.I haven't taken TKI medication recently.I am 18 years old or older.I am currently taking metformin.I have not had radiation therapy in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort 1A
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.
What maladies does Abemaciclib commonly ameliorate?
"Abemaciclib is a popular treatment option for breast cancer, and has also been employed to address anovulatory cycle, tamoxifen, and disease."
Answered by AI
Are there any other experiments that have been undertaken utilizing Abemaciclib?
"At present, 230 trials are exploring the effects of Abemaciclib on a variety of patients. Of those studies, 50 have progressed to phase 3 and they can be found in San Francisco with an additional 15292 sites conducting similar research across the world."
Answered by AI
Are applications still being accepted for this clinical trial?
"That is accurate. Per the clinicaltrials.gov website, this trial initiated recruitment on December 24th 2018 and was recently updated on May 23rd 2022; 40 participants are required between 3 different medical facilities."
Answered by AI
How many participants are actively engaging in this clinical research?
"Affirmative. Clinicaltrials.gov data indicates that this research project, which was originally posted on December 24th 2018, is currently seeking participants. Around 40 individuals need to be enrolled from 3 separate medical facilities."
Answered by AI
Has the Federal Drug Administration given its endorsement to Abemaciclib?
"Abemaciclib's safety ranking is set to 2, due to the lack of efficacy evidence in its Phase 2 trial. However, there are some existing data points that support this drug's security."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger