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

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center

Criteria

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

• Must be able to swallow ribociclib capsules/tablets

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