Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase II Single Arm Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma
The purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).
The expected duration of this study is 36 months (24 months accrual period and 12 month
follow up period). Enrollment into the screening or treatment phase of the study will be
stopped when the actual subject numbers have been achieved.
This single arm single institution, open label, prospective, phase II trial will evaluate
the efficacy and safety of oral 600mg/daily in 28 day cycles of ribociclib in advanced
well-differentiated liposarcoma (WDL) and de-differentiated liposarcoma (DDL) patients.
Number of patients in the study will reflect the reconciliation between statistical
requirements and incidence.
Treatment will continue until disease progression, development of unacceptable toxicity,
noncompliance or withdrawal of consent by the patient or investigator decision.
All screening requirements must be completed within 28 days of the visit (except for CDK4/6
amplification and pRb, p16 and cyclin D staining status which may be completed in advance).
Patients will be examined on cycle 1 day-1 and every 2 weeks, including complete blood count
(CBC) and chemistry, for the first 8 weeks of treatment, and thereafter every month until
disease progression. CT/MRI imaging (contrast) will be performed every 8 weeks for response
evaluation. Clinical benefit as well as individual categories of response (complete response
(CR), partial response (PR), stable disease (SD) and progressive disease (PD) will be
determined using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST). Response
duration endpoints, including PFS, PFS at 12 weeks and OS will be assessed using the
Kaplan-Meier method. Toxicity (AEs) will be recorded using the NCI- Common Toxicity Criteria
for Adverse Effects v 4.03 (NCI-CTCAE). Screening procedures will include quantitative
analysis of CDK4 gene copy number using FISH, immunostaining for p16 and cyclin D1 all using
formalin fixed paraffin embedded (FFPE) tissue sections. In addition tumor DNA, extracted
from FFPE tissue (after choosing optimal area by a Pathologist), will be submitted to a next
generation sequencing analysis ("ion ampliseq" cancer panel v2©) for a later exploratory
analysis.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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