48 Participants Needed

Ribociclib + Everolimus for Dedifferentiated Liposarcoma and Leiomyosarcoma

Recruiting at 1 trial location
Mv
Overseen ByMargaret von mehren, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Fox Chase Cancer Center
Must be taking: Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, Ribociclib and Everolimus, in patients with advanced DDL and LMS who have not responded to previous treatments. Ribociclib blocks proteins that help cancer grow, while Everolimus stops cancer cells from multiplying. Everolimus is an oral mTOR inhibitor that is approved for various cancers, including renal cell carcinoma and breast cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong inducers or inhibitors of CYP3A4/5, at least 7 days before starting the study drug. If you are on these medications, you will need to discuss with your doctor about stopping them before joining the trial.

What safety data exists for the use of Everolimus in humans?

Everolimus, used for various cancers, is generally well tolerated but can cause side effects like mouth sores, rash, infections, lung inflammation, and high blood sugar. In some cases, these side effects can be severe, leading to treatment discontinuation.12345

How is the drug combination of Ribociclib and Everolimus unique for treating dedifferentiated liposarcoma and leiomyosarcoma?

The combination of Ribociclib and Everolimus is unique because it targets specific pathways involved in tumor growth, such as the CDK4 and mTOR pathways, which are often amplified in these sarcomas. This approach is different from traditional chemotherapy, which is less targeted and often has more side effects.678910

What data supports the effectiveness of the drugs Ribociclib and Everolimus for treating dedifferentiated liposarcoma and leiomyosarcoma?

While there is no direct data on the combination of Ribociclib and Everolimus for these specific cancers, similar drugs like the CDK4 inhibitor abemaciclib have shown potential benefits in treating dedifferentiated liposarcoma by targeting specific tumor characteristics. This suggests that Ribociclib, which is also a CDK4 inhibitor, might offer some benefit in this context.6781112

Who Is on the Research Team?

Margaret von Mehren | Fox Chase Cancer ...

Margaret von Mehren, MD

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion 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 not had systemic therapy for my condition.
See 7 more

Exclusion Criteria

I have a stomach or intestine problem that affects how I absorb medicine.
Patient has any other concurrent severe and/or uncontrolled medical condition
I do not have uncontrolled heart disease or abnormal heart rhythms.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ribociclib orally at 300 mg/day for 21 days of each 28-day cycle and Everolimus 2.5 mg orally on a continuous 28-day cycle. Clinical and laboratory assessments are made on day 1, day 15 of cycle 1 and 2, and day 1 of each subsequent cycle.

Until disease progression, unacceptable toxicity, or withdrawal of consent
Day 1 and day 15 of cycle 1 and 2, and day 1 of each subsequent cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment. Tumor response is assessed by RECIST 1.1 at week 8, 16, 24, and every 12 weeks thereafter.

Through study completion

Long-term follow-up

Participants are followed until death or are lost to follow-up for analysis of secondary endpoints.

What Are the Treatments Tested in This Trial?

Interventions

  • Everolimus
  • Ribociclib
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Leiomyosarcoma ArmExperimental Treatment2 Interventions
Group II: Dedifferentiated Liposarcoma ArmExperimental Treatment2 Interventions

Everolimus is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Afinitor for:
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Approved in European Union as Votubia for:
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Approved in United States as Zortress for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Published Research Related to This Trial

In a study of 61 patients with well-differentiated and dedifferentiated liposarcoma treated with palbociclib, the median progression-free survival was only 9.2 months for WDLPS and 2.6 months for DDLPS, indicating limited efficacy of the treatment.
Surgical outcomes showed that while some patients underwent successful resections after palbociclib treatment, there was no overall survival benefit, and the treatment did not significantly prolong tumor control.
Real-world use of palbociclib monotherapy in retroperitoneal liposarcomas at a large volume sarcoma center.Nassif, EF., Cope, B., Traweek, R., et al.[2023]
In a phase II trial involving 10 patients with advanced solid tumors and specific genetic alterations, everolimus did not show significant anti-tumor activity, as no complete or partial responses were observed, and the study did not progress to the second stage.
Despite the lack of efficacy, everolimus was well-tolerated, with no severe toxicities reported, indicating a safety profile that warrants further exploration with different treatment strategies.
Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy.Kim, ST., Lee, J., Park, SH., et al.[2022]
Everolimus, an oral mTOR inhibitor, significantly improves progression-free survival in patients with clear cell renal cancer, increasing it from a median of 1.9 months to 4.9 months in a phase III trial with a hazard ratio of 0.33 (P < 0.001).
The treatment is generally well-tolerated, with mild to moderate side effects that can be managed, and it has been approved as a validated option for patients who have progressed on VEGFR inhibitors, with ongoing trials exploring its use in combination therapies.
Everolimus: the first approved product for patients with advanced renal cell cancer after sunitinib and/or sorafenib.Coppin, C.[2021]

Citations

A Single-Arm Phase Ib/II Study of Lenvatinib plus Eribulin in Advanced Liposarcoma and Leiomyosarcoma. [2023]
Real-world use of palbociclib monotherapy in retroperitoneal liposarcomas at a large volume sarcoma center. [2023]
Dedifferentiated Liposarcoma: Systemic Therapy Options. [2021]
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Regorafenib Versus Placebo in Advanced/Metastatic, Treatment-Refractory Liposarcoma: Results from the SARC024 Study. [2021]
Anti-Tumor Effect of Apatinib and Relevant Mechanisms in Liposarcoma. [2022]
Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy. [2022]
Management of adverse events in patients with hormone receptor-positive breast cancer treated with everolimus: observations from a phase III clinical trial. [2021]
Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma. [2022]
Everolimus: the first approved product for patients with advanced renal cell cancer after sunitinib and/or sorafenib. [2021]
[Tolerablity of everolimus in clinical practice: a retrospective study]. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Frequent amplification of receptor tyrosine kinase genes in welldifferentiated/ dedifferentiated liposarcoma. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Myxoid liposarcoma and the mammalian target of rapamycin pathway. [2021]
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