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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.
Must not have
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
Patients with a known hypersensitivity to ribociclib or everolimus or to its excipients.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing a new drug combination for advanced or recurrent endometrial cancer. It targets patients whose cancer has spread or returned. The treatment works by blocking enzymes needed for cancer cell growth and by stopping the cells from dividing or spreading. Anlotinib is a new drug that targets multiple aspects of cancer growth.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had major surgery or recovered from its major side effects within the last 14 days.
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I am allergic to ribociclib, everolimus, or their ingredients.
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I am not taking strong CYP3A4/5 drugs, certain supplements, hormone therapies, or warfarin.
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I do not have serious heart problems or abnormal heart rhythms.
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I have severe liver disease.
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I have previously been treated with an mTOR inhibitor.
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I do not have major stomach or bowel problems that could affect how I absorb medication.
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My cancer is a specific type of uterine cancer.
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I don't have Long QT syndrome, sudden death in family, or risk factors for Torsades de Pointe.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate (CBR)
Awards & Highlights
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.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Ribociclib, Everolimus, and Letrozole are targeted therapies used in treating endometrial cancer. Ribociclib inhibits CDK4/6 enzymes, preventing tumor cell proliferation.
Everolimus targets the mTOR pathway, reducing cell growth and survival. Letrozole lowers estrogen levels, slowing the growth of hormone receptor-positive cancer cells.
These mechanisms are crucial for selecting effective treatments, particularly for advanced or recurrent endometrial cancer, offering a more personalized and potentially more effective approach to managing the disease.
Phase Ib Dose-escalation/Expansion Trial of Ribociclib in Combination With Everolimus and Exemestane in Postmenopausal Women with HR<sup>+</sup>, HER2<sup>-</sup> Advanced Breast Cancer.Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma.Hormonal therapy in advanced or recurrent endometrial cancer.
Phase Ib Dose-escalation/Expansion Trial of Ribociclib in Combination With Everolimus and Exemestane in Postmenopausal Women with HR<sup>+</sup>, HER2<sup>-</sup> Advanced Breast Cancer.Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma.Hormonal therapy in advanced or recurrent endometrial cancer.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,053 Previous Clinical Trials
1,798,659 Total Patients Enrolled
24 Trials studying Endometrial Cancer
6,124 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.
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