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

Sponsor
Hadassah Medical Organization
Study ID
NCT02571829
Phase
PHASE2
Status
Unknown

Conditions

  • Liposarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ribociclib — DRUG
    Oral, 600 mg x 1 a day, duration - according to response

Study Details

The purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).

Key Dates

Start date
May 31, 2016
Status verified
Nov 2016
Primary completion
Aug 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ribociclib
    single arm ribociclib Oral 600 mg x 1 a day duration according to response.

Primary Outcome Measure

Response to therapy as evaluated by RECIST 1.1 and Choi [ Time Frame: 36 months (24 months accrual period and 12 month follow up period) ]

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