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

• Status: Unknown status
• Trial end date: 2017-10-01
• 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: Hadassah Medical Organization

Criteria

Inclusion Criteria:

1. Written informed consent

2. Age ≥ 18 years

3. Histological confirmed diagnosis of WDL/DDL with metastatic or locally advanced disease not amenable to complete resection.

4. WDL/DDL patients must have documentation of disease progression within 6 months prior to study entry.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

6. Measurable disease by RECIST v1.1 criteria. At least one measurable lesion located outside of a previously irradiated area.

7. 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.

8. Patient has adequate bone marrow and organ function.

9. Must be able to swallow ribociclib capsules/tablets.

Exclusion Criteria:

1. A known hypersensitivity to ribociclib or any of its excipients.

2. 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.

3. Patients with central nervous system (CNS) involvement at least 4 weeks from prior therapy completion

4. 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)

5. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 msec

6. Participation in a prior investigational study within 30 days prior to enrollment

7. Patient has had major surgery within 14 days prior to starting study drug