Active — Not RecruitingPhase 2

Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)

United States48 participantsStarted 2017-08-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Step 1: * Male or female patients 18 years or older. * Patients must have locally advanced, metastatic or refractory leiomyosarcoma or dedifferentiated liposarcoma. * A) Patients enrolled into the dedifferentiated cohort do not require prior systemic therapy (may be naive to systemic therapy). B) Leiomyosarcoma patients must have had at least 1 prior systemic therapy (does not include adjuvant/neoadjuvant therapy in a curative setting). There is no limits on prior number of therapies for either cohort. * Measurable disease per RECIST 1.1 * Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment. * Time since the last prior therapy to treat underlying malignancy to start of drug: * Cytotoxic chemotherapy: greater than the duration of the most recent cycle of the previous regimen (with a minimum of two weeks for all) * Biologic therapy (e.g., antibodies): ≥ four weeks * ≥ 5 x t1/2 of a small molecule therapeutic, not otherwise defined above, with a minimum of 2 weeks (including aromatase inhibitors and tamoxifen). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements. * Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening: * Absolute neutrophil count ≥1.5 × 109/L * P…

What they're measuring

Antitumor activity of Ribociclib in combination with Everolimus in advanced LMS or DDL

Timeframe: 16 weeks

Trial details

NCT IDNCT03114527

SponsorFox Chase Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-12