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mTOR inhibitor
Everolimus + Letrozole +/- Ribociclib for Endometrial Cancer
Phase 2
Waitlist Available
Led By Pamela T Soliman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estimated glomerular filtration rate (eGFR) >= 30mL/min/1.73m^2 (at screening) according to the Modification of Diet in Renal Disease (MDRD) formula.
Patients must have advanced or recurrent disease that is refractory to curative treatment based on imaging or clinical exam.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat endometrial cancer. The drugs may work better together than alone in treating the cancer.
Who is the study for?
This trial is for patients with advanced or recurrent endometrial carcinoma who have had no more than two prior chemotherapy regimens and are not currently pregnant or breastfeeding. They must be able to provide informed consent, have a GOG performance status of 0 to 1, and meet specific blood count and organ function criteria. Prior radiation therapy and letrozole treatment are acceptable under certain conditions.Check my eligibility
What is being tested?
The study is testing the effectiveness of everolimus combined with letrozole, with or without ribociclib, in treating endometrial cancer that has spread or returned. Ribociclib blocks enzymes needed for cell growth while everolimus and letrozole work by killing cells, stopping division, or preventing spread.See study design
What are the potential side effects?
Potential side effects include risks associated with blocking enzyme functions which may affect tumor growth but also normal cell processes. This can lead to fatigue, digestive issues, changes in blood counts affecting overall health, possible heart rhythm problems due to QT interval prolongation from ribociclib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by eGFR, is adequate.
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My disease cannot be cured with treatment and is getting worse.
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My liver function tests are within the required range.
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My kidney function is within the normal range.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one tumor that can be measured and has not been previously treated with radiation.
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I haven't taken any cancer treatments or immunologic agents for the last 4 weeks.
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I have been diagnosed with a specific type of uterine cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit rate (CBR)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (everolimus, letrozole)Experimental Treatment2 Interventions
Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (ribociclib, everolimus, letrozole)Experimental Treatment3 Interventions
Patients receive ribociclib PO QD, everolimus PO QD, and letrozole PO QD on days 1-28. 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
Letrozole
FDA approved
Ribociclib
FDA approved
Everolimus
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,226 Total Patients Enrolled
22 Trials studying Endometrial Cancer
5,454 Patients Enrolled for Endometrial Cancer
Pamela T SolimanPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the last 3 years, except for certain skin cancers or treated cervical cancer.My kidney function, measured by eGFR, is adequate.I haven't had major surgery or recovered from its major side effects within the last 14 days.I haven't had any cancer treatments in the last 4 weeks.My disease cannot be cured with treatment and is getting worse.Your platelet count should be at least 100 billion per liter at the screening.I am allergic to ribociclib, everolimus, or their ingredients.I am not on long-term steroids or immunosuppressants, except for short-term or local use.I am not taking strong CYP3A4/5 drugs, certain supplements, hormone therapies, or warfarin.You have had HIV in the past. Testing for HIV is not required.I am willing and able to follow the study's requirements.My liver function tests are within the required range.I have had 2 or fewer chemotherapy treatments for recurrent endometrial cancer.Your blood clotting test result (INR) must be less than or equal to 1.5.My kidney function is within the normal range.I am not pregnant, breastfeeding, and cannot become pregnant due to surgery or menopause.Your bilirubin levels need to be within a certain range, unless you have well-documented Gilbert's syndrome.I have recovered from previous cancer treatment side effects, except for mild neuropathy, hair loss, or stopped periods.I am fully active or restricted in physically strenuous activity but can do light work.I do not have serious heart problems or abnormal heart rhythms.Your heart's electrical activity (measured by ECG) should show a specific QT interval and a resting heart rate within a certain range.I have at least one tumor that can be measured and has not been previously treated with radiation.I have severe liver disease.I have stopped taking letrozole for at least 10 days.My brain involvement is stable, and I haven't had brain treatment or taken specific medications for it in the last 4 weeks.I have had radiation therapy before.Your hemoglobin level should be at least 9.0 grams per deciliter when tested before the study.I have previously been treated with an mTOR inhibitor.Your systolic blood pressure is too high (over 160 mmHg) or too low (under 90 mmHg) during screening.You have enough infection-fighting white blood cells in your body.I do not have major stomach or bowel problems that could affect how I absorb medication.I haven't had any live vaccines in the last week and will avoid them during the study.I haven't taken any cancer treatments or immunologic agents for the last 4 weeks.My cancer is a specific type of uterine cancer.I don't have Long QT syndrome, sudden death in family, or risk factors for Torsades de Pointe.I have been diagnosed with a specific type of uterine cancer.I agree to a tumor biopsy or have had one in the last 3 months without treatment since.Your cholesterol and triglyceride levels should be within certain limits when fasting.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (ribociclib, everolimus, letrozole)
- Group 2: Arm II (everolimus, letrozole)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Are people still able to sign-up for this research project?
"That is correct. The trial, which was initially posted on August 18th 2017 and has since been updated September 22nd of this year, is currently looking for 87 individuals across 2 locations."
Answered by AI
Are there any known dangers associated with taking Ribociclib?
"While Phase 2 trials are not as conclusive as Phase 3, there is some evidence suggesting that Ribociclib is safe."
Answered by AI
Are there any other ongoing investigations with Ribociclib?
"Currently, 285 studies are being conducted on the efficacy of ribociclib. 63 of those trials are in phase 3. Most research is coming out of Shanghai, but there are 15778 total locations running these tests."
Answered by AI
How many study participants are there in this clinical trial?
"That is correct, the clinical trial is still open and currently recruiting patients. The original posting was on August 18th, 2017 with the most recent update being September 22nd, 2022. There are 87 positions available at 2 different locations."
Answered by AI
What does Ribociclib commonly help with?
"Ribociclib is a medication that transplant patients often take to prevent organ rejection. It can also be used to treat waldenstrom macroglobulinemia, tamoxifen, and other kidney or liver conditions."
Answered by AI
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