This is a two center, 2 arm, Phase II study evaluating the combination of Ribociclib and
Everolimus in patients with advanced DDL and LMS who have had at least 1 prior systemic
therapy. Patients will be enrolled by sarcoma histology into DDL (Arm A) and LMS (Arm B). The
purpose of this study is to determine the anti-tumor activity of this doublet therapy in
these patient cohorts. Ribociclib will be administered orally at 300 mg/day 3 weeks on/1 week
off. Everolimus will be administered 2.5 mg orally on a continuous 28 day cycle. Clinical and
laboratory assessments will be made on day 1, d15 of cycle 1 and 2, and day 1 of each
subsequent cycle. Tumor response will be assessed by RECIST 1.1 at (CT or MRI) at week 8, 16,
24 and every 12 weeks thereafter. Study drug administration will continue until disease
progression, unacceptable toxicity or withdrawal of consent. Patients will be followed until
death or are lost to follow-up for analysis of secondary endpoints.
There will be a 1 step registration process for dedifferentiated liposarcoma patients while
patients with leiomyosarcoma will require a 2 step registration process. For step 1 of
registration, patients must meet all the eligibility criteria necessary for step 1. For step
2 registration, patients must meet the inclusion criteria necessary for step 2 to be enrolled
into the study.
Connective and Soft Tissue Neoplasm,
All Solid Tumors,
Soft Tissue Sarcoma,
soft tissue sarcomas
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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