Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03096912
Status:
UNKNOWN
Last Update Posted:
2017-10-25
First Post:
2016-11-29
Brief Title:
A Study Assessing Efficacy Safety of Ribociclib in Patients With Advanced WellDedifferentiated Liposarcoma
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
A Phase II Single Arm Study Assessing Efficacy Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive welldedifferentiated liposarcoma WDLDDL
Detailed Description:
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 600mgdaily 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 CDK46 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 CTMRI 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 11 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 403 NCI-CTCAE Screening procedures will include medical history physical examination blood test baseline CTMRI imaging and formalin-fixed tissue submission for FoundationOne mutational analysis
This single arm single institution open label prospective phase II trial will evaluate the efficacy and safety of oral 600mgdaily 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 CDK46 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 CTMRI 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 11 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 403 NCI-CTCAE Screening procedures will include medical history physical examination blood test baseline CTMRI imaging and formalin-fixed tissue submission for FoundationOne mutational analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None