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

Sponsor
Assaf-Harofeh Medical Center
Study ID
NCT03096912
Phase
PHASE2
Status
Unknown

Conditions

  • Liposarcoma - Well Differentiated
  • Liposarcoma; Mixed Type
  • Liposarcomas, Dedifferentiated
  • Soft-Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    Ribociclib Oral 600 mg x 1 a day 21 days on 1 week off in 28 days cycles

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
Jul 31, 2016
Status verified
Oct 2017
Primary completion
Dec 31, 2019
Completion
Apr 30, 2020

Study Design

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

Arms

  • Experimental: Ribociclib
    Oral, ribociclib 600 mg x 1 a day, 21 days on 7 days off

Primary Outcome Measure

Response to therapy as evaluated by RECIST 1.1 [ Time Frame: 36 months ]

Central Contacts

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