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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
Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after final treatment on study
Awards & highlights
No Placebo-Only Group

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 below
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My cancer is a type of sarcoma that has spread or is not responding to treatment.
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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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My blood tests show my organs and bone marrow are working well.
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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 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

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 more

Side effects data

From 2023 Phase 3 trial • 726 Patients • NCT02422615
Infinity%
Cholelithiasis
Infinity%
Cerebrovascular accident
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Nausea
Infinity%
Metastases to central nervous system
Infinity%
Depression
Infinity%
Infusion related reaction
Infinity%
Anxiety
Infinity%
Gastrointestinal haemorrhage
Infinity%
Urinary tract infection
Infinity%
Arthralgia
Infinity%
Drug-induced liver injury
Infinity%
Decreased appetite
Infinity%
Back pain
Infinity%
Influenza like illness
Infinity%
Presyncope
Infinity%
Acute hepatic failure
Infinity%
Diarrhoea
Infinity%
Hypophagia
Infinity%
Asthenia
Infinity%
Urosepsis
Infinity%
Endometrial cancer
Infinity%
Cerebral haemorrhage
Infinity%
Abdominal pain
Infinity%
Upper respiratory tract infection
Infinity%
Fatigue
Infinity%
Metastases to lung
Infinity%
Femur fracture
Infinity%
Hip fracture
Infinity%
Malignant melanoma
Infinity%
Thrombocytopenia
Infinity%
Dehydration
Infinity%
Mental status changes
Infinity%
Cancer pain
Infinity%
Abdominal pain upper
Infinity%
Constipation
Infinity%
Pyrexia
Infinity%
Hypotension
Infinity%
Oedema peripheral
Infinity%
Blood creatinine increased
Infinity%
Electrocardiogram QT prolonged
Infinity%
Gamma-glutamyltransferase increased
Infinity%
Pain in extremity
Infinity%
Dizziness
Infinity%
Dyspnoea
Infinity%
Oropharyngeal pain
Infinity%
Pruritus
Infinity%
General physical health deterioration
Infinity%
Pleural effusion
Infinity%
Respiratory failure
Infinity%
Alanine aminotransferase increased
Infinity%
Aspartate aminotransferase increased
Infinity%
Neutrophil count decreased
Infinity%
White blood cell count decreased
Infinity%
Bone pain
Infinity%
Neck pain
Infinity%
Headache
Infinity%
Alopecia
Infinity%
Dry skin
Infinity%
Vomiting
Infinity%
Pneumothorax
Infinity%
Pulmonary embolism
Infinity%
Dry mouth
Infinity%
Dyspepsia
Infinity%
Myalgia
Infinity%
Insomnia
Infinity%
Cough
Infinity%
Cardiomyopathy
Infinity%
Adrenal insufficiency
Infinity%
Ascites
Infinity%
Humerus fracture
Infinity%
Subdural haematoma
Infinity%
Blood alkaline phosphatase increased
Infinity%
Osteonecrosis of jaw
Infinity%
Asthma
Infinity%
Dyspnoea exertional
Infinity%
Supraventricular tachycardia
Infinity%
Tachycardia
Infinity%
Influenza
Infinity%
Lower respiratory tract infection
Infinity%
Hypercalcaemia
Infinity%
Anaemia
Infinity%
Neutropenia
Infinity%
Stomatitis
Infinity%
Nasopharyngitis
Infinity%
Muscle spasms
Infinity%
Musculoskeletal chest pain
Infinity%
Musculoskeletal pain
Infinity%
Rash
Infinity%
Hot flush
Infinity%
Hypertension
3%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Fulvestrant (On-treatment)
Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)
Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival Follow-up)
Crossover to Ribociclib + Fulvestrant (Crossover On-treatment)
Ribociclib + Fulvestrant (On-treatment)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
~5080
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,424 Total Patients Enrolled
Margaret von Mehren, MDPrincipal InvestigatorFox Chase Cancer Center
10 Previous Clinical Trials
399 Total Patients Enrolled

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03114527 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Dedifferentiated Liposarcoma Arm, Leiomyosarcoma Arm
Soft Tissue Sarcoma Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT03114527 — Phase 2
Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03114527 — Phase 2

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
~2 spots leftby Jun 2024