Ribociclib for Liposarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liposarcoma+3 More
Ribociclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Liposarcoma
  • Soft Tissue Sarcoma (STS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Through study completion

16 weeks
Antitumor activity of Ribociclib in combination with Everolimus in advanced LMS or DDL
Through study completion
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Day 30
Number of participants with treatment-related adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Ribociclib + Adjuvant Endocrine Therapy (ET)
54%Neutropenia
46%Fatigue
46%Nausea
38%White blood cell count decreased
27%Neutrophil count decreased
27%Cough
27%Alopecia
23%Constipation
23%Diarrhoea
23%Arthralgia
23%Anaemia
19%Nasopharyngitis
19%Upper respiratory tract infection
19%Headache
19%Alanine aminotransferase increased
19%Abdominal pain
15%Lymphocyte count decreased
15%Pyrexia
15%Oropharyngeal pain
15%Back pain
15%Musculoskeletal chest pain
15%Blood creatinine increased
15%Dizziness
15%Vomiting
15%Gastrooesophageal reflux disease
12%Lymphoedema
12%Urinary tract infection
12%Pain in extremity
12%Aspartate aminotransferase increased
12%Stomatitis
12%Pain
12%Thrombocytopenia
12%Musculoskeletal pain
12%Hot flush
12%Oedema peripheral
12%Abdominal pain upper
8%Herpes zoster
8%Palpitations
8%Sinusitis
8%Neck pain
8%Hypomagnesaemia
8%Muscle spasms
8%Procedural pain
8%Bone pain
8%Blood calcium decreased
8%Myalgia
8%Upper respiratory tract congestion
8%Wheezing
8%Vision blurred
8%Breast pain
8%Chest pain
8%Pneumonia
8%Weight increased
8%Influenza
8%Fall
8%Contusion
8%Blood cholesterol increased
8%Hypokalaemia
8%Dysgeusia
8%Nasal congestion
8%Rhinitis allergic
8%Rash
8%Productive cough
8%Confusional state
8%Neuropathy peripheral
8%Pollakiuria
8%Influenza like illness
8%Leukopenia
8%Upper-airway cough syndrome
4%Cardiac failure congestive
4%Acute myeloid leukaemia
4%Cellulitis
4%Disseminated intravascular coagulation
4%Pulmonary embolism
4%Breast cellulitis
4%Axillary pain
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03078751) in the Ribociclib + Adjuvant Endocrine Therapy (ET) ARM group. Side effects include: Neutropenia with 54%, Fatigue with 46%, Nausea with 46%, White blood cell count decreased with 38%, Neutrophil count decreased with 27%.

Trial Design

2 Treatment Groups

Leiomyosarcoma Arm
1 of 2
Dedifferentiated Liposarcoma Arm
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Ribociclib · No Placebo Group · Phase 2

Leiomyosarcoma ArmExperimental Group · 2 Interventions: Everolimus, Ribociclib · Intervention Types: Drug, Drug
Dedifferentiated Liposarcoma ArmExperimental Group · 2 Interventions: Everolimus, Ribociclib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Ribociclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
215 Previous Clinical Trials
33,577 Total Patients Enrolled
Margaret von Mehren, MDPrincipal InvestigatorFox Chase Cancer Center
10 Previous Clinical Trials
399 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients enrolled into the dedifferentiated cohort do not require prior systemic therapy
This means that biologic therapy, such as antibodies, should be taken for at least four weeks.
A person with ECOG performance status 0-1 is generally healthy and able to carry out normal activities.
In order to be eligible for Cycle 1 of the study, patients must have completed at least two weeks of their most recent cycle of their previous chemotherapy regimen.
≥ 5 times the half-life of a small molecule therapeutic, not otherwise defined above, with a minimum of 2 weeks (including aromatase inhibitors and tamoxifen).
The patient has agreed to the screening procedures and is able to follow the protocol.
The patient has a measurable disease according to RECIST 1.1.
Patients who are at least 18 years old and male or female.
Patients with locally advanced, metastatic or refractory leiomyosarcoma or dedifferentiated liposarcoma are eligible for this study.
Radiological or objective evidence that the cancer has returned or progressed since the patient's last systemic therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.