UnknownPhase 2

A Phase II Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma

Israel30 participantsStarted 2016-05

Plain-language summary

The purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent
✓. Age ≥ 18 years
✓. Histological confirmed diagnosis of WDL/DDL with metastatic or locally advanced disease not amenable to complete resection.
✓. WDL/DDL patients must have documentation of disease progression within 6 months prior to study entry.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Measurable disease by RECIST v1.1 criteria. At least one measurable lesion located outside of a previously irradiated area.
✓. Formalin fixed paraffin embedded tumor blocs and representative hematoxylin/eosin slides (preferably both) should be provided for immunohistochemistry staining and molecular analysis of 50 gene signature panel and must have increased CDK4 gene copy number (at least \>/=3) and proficient Rb gene.
✓. Patient has adequate bone marrow and organ function.

Exclusion criteria

✕. A known hypersensitivity to ribociclib or any of its excipients.
✕. A concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
✕. Patients with central nervous system (CNS) involvement at least 4 weeks from prior therapy completion
✕. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening)
✕. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \>450 msec
✕. Participation in a prior investigational study within 30 days prior to enrollment
✕. Patient has had major surgery within 14 days prior to starting study drug

What they're measuring

Response to therapy as evaluated by RECIST 1.1 and Choi

Timeframe: 36 months (24 months accrual period and 12 month follow up period)

Trial details

NCT IDNCT02571829

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

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