A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma
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|ClinicalTrials.gov Identifier: NCT03096912|
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liposarcomas, Dedifferentiated Liposarcoma - Well Differentiated Liposarcoma; Mixed Type Soft-Tissue Sarcoma||Drug: Ribociclib||Phase 2|
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 medical history, physical examination, blood test, baseline CT/MRI imaging and formalin-fixed tissue submission for FoundationOne mutational analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single Arm Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||April 2020|
Oral, ribociclib 600 mg x 1 a day, 21 days on 7 days off
Ribociclib Oral 600 mg x 1 a day 21 days on 1 week off in 28 days cycles
Other Name: LEE011
- Response to therapy as evaluated by RECIST 1.1 [ Time Frame: 36 months ]
- Response to therapy as evaluated by Choi [ Time Frame: 36 months ]
- Median PFS [ Time Frame: 36 months ]PFS will be computed from the date of start of treatment to the first documented date of progression or the date of death, due to any cause assessed by investigator.
- PFS assessed at 12 weeks [ Time Frame: 12 weeks ]Number of total patients who are PFS at 12 weeks of treatment
- Overall survival (OS) [ Time Frame: 36 months ]will be computed from the date of start of treatment to the date of death, due to any cause. Patients alive or lost for follow-up at the time of the analysis will be censored at the date of last follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096912
|Contact: Daniela Katz, M.Demail@example.com|
|Contact: Sharona Ben Amifirstname.lastname@example.org|
|Assaf Harofeh Medical Center||Recruiting|
|Be'er Ya'aqov, Israel, 70300|
|Contact: Daniela Katz, MD 97289778144 email@example.com|
|Contact: Sharona Ben Ami 97289778003 firstname.lastname@example.org|
|Principal Investigator:||Daniela Katz, M.D||Assaf-Harofeh Medical Center|