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mTOR Inhibitor
Ribociclib + Everolimus for Dedifferentiated Liposarcoma and Leiomyosarcoma
Phase 2
Waitlist Available
Led By Margaret von Mehren, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have locally advanced, metastatic or refractory leiomyosarcoma or dedifferentiated liposarcoma
Patient has adequate bone marrow and organ function as defined by specified laboratory values at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after final treatment on study
Awards & highlights
Study Summary
This trial is testing a combination of two drugs, Ribociclib and Everolimus, to treat patients with advanced dedifferentiated liposarcoma or leiomyosarcoma who have had at least one prior systemic therapy. The drugs will be given orally, and the trial will last until disease progression, unacceptable toxicity, or withdrawal of consent.
Who is the study for?
Adults with advanced dedifferentiated liposarcoma (DDL) or leiomyosarcoma (LMS) who've had at least one prior systemic therapy can join this trial. They should be in good physical condition, able to take oral medication, and have measurable disease progression after their last treatment. Women must not be pregnant or nursing, and all participants must agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing a combination of two drugs: Ribociclib taken orally for three weeks with a one-week break, and Everolimus taken continuously every day. The goal is to see how well these drugs work together against DDL and LMS by monitoring tumor response using scans at specific intervals.See study design
What are the potential side effects?
Possible side effects include risks associated with bone marrow suppression which could lead to blood disorders, organ dysfunction due to the drug's toxicity, gastrointestinal issues affecting absorption of the drugs, heart problems including abnormal heart rhythms, and potential interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of sarcoma that has spread or is not responding to treatment.
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My blood tests show my organs and bone marrow are working well.
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My cancer has worsened or returned after my last treatment.
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I am fully active or can carry out light work.
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I can swallow pills without difficulty.
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My leiomyosarcoma tumor has normal Rb protein levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antitumor activity of Ribociclib in combination with Everolimus in advanced LMS or DDL
Secondary outcome measures
Number of participants with treatment-related adverse events
Objective response rate (ORR)
Overall survival (OS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Leiomyosarcoma ArmExperimental Treatment2 Interventions
Patients receive ribociclib orally at 300mg/day for 21 days of each 28 day cycle and everolimus 2.5mg orally on a continuous 28 day cycle.
Group II: Dedifferentiated Liposarcoma ArmExperimental Treatment2 Interventions
Patients receive ribociclib orally at 300mg/day for 21 days of each 28 day cycle and everolimus 2.5mg orally on a continuous 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330
Everolimus
2010
Completed Phase 4
~1510
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,461 Total Patients Enrolled
Margaret von Mehren, MDPrincipal InvestigatorFox Chase Cancer Center
10 Previous Clinical Trials
399 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of sarcoma that has spread or is not responding to treatment.My blood tests show my organs and bone marrow are working well.I have a stomach or intestine problem that affects how I absorb medicine.I do not have uncontrolled heart disease or abnormal heart rhythms.I have been treated with CDK4/6 or mTOR inhibitors before.I have recently undergone radiotherapy.I still have side effects from cancer treatment that are not mild.I had major surgery recently.I am a sexually active male not using condoms.I am 18 years old or older.I have not had systemic therapy for my condition.I have leiomyosarcoma and have undergone at least one systemic therapy.My cancer has worsened or returned after my last treatment.I haven't had cancer in the last 3 years, except for certain types.My liver disease is moderately to severely advanced.I am of childbearing age and not using effective birth control.I am fully active or can carry out light work.I am allergic to ingredients in Ribociclib or Everolimus.I can swallow pills without difficulty.My leiomyosarcoma tumor has normal Rb protein levels.I am currently taking warfarin or a similar blood thinner.My brain or spinal cord cancer meets specific conditions.I have taken steroids within the last 2 weeks or am currently taking them.I am on medications that I can't stop a week before starting the study drug.I have a known history of HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Dedifferentiated Liposarcoma Arm
- Group 2: Leiomyosarcoma Arm
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.
How many individuals are part of this research project?
"This trial is no longer active. It was originally posted on 8/8/2017 and ended on 6/1/2022. For those interested, there are 495 other trials recruiting patients with liposarcoma and 146 studies involving Ribociclib that are still open."
Answered by AI
What are the primary purposes for which patients take Ribociclib?
"While ribociclib is frequently used to treat kidney transplants, it can also be effective in managing waldenstrom macroglobulinemia, lung cancer, and advanced carcinoid tumors."
Answered by AI
Are there other ongoing investigations into Ribociclib's effects?
"The first ever study for ribociclib was completed in 2008 at the Sheba Medical Center. In total, there have been 432 completed studies since then. As of now, there are 146 active trials recruiting patients. A large concentration these medical trials are taking place in Philadelphia, Pennsylvania."
Answered by AI
What is the status of Ribociclib in regards to federal approval?
"Because there is only evidence of safety in phase 2 trials, and no efficacy data, we have given Ribociclib a score of 2."
Answered by AI
Are there any unfilled participant positions in this research?
"This trial is no longer recruiting patients. The first posting was on 8/8/2017, with the most recent edit being on 6/1/2022. 495 other trials are currently searching for liposarcoma patients and 146 different trials are looking for Ribociclib participants."
Answered by AI
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