NCT03096912

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

November 29, 2016

Last Update Submit

October 24, 2017

Conditions

Liposarcomas, DedifferentiatedLiposarcoma - Well DifferentiatedLiposarcoma; Mixed TypeSoft-Tissue Sarcoma

Keywords

CDK4 inhibitorLEE011ribociclibliposarcoma dedifferentiatedliposarcoma well differentiated

Outcome Measures

Primary Outcomes (2)

  • Response to therapy as evaluated by RECIST 1.1

    36 months

  • Response to therapy as evaluated by Choi

    36 months

Secondary Outcomes (3)

  • Median PFS

    36 months

  • PFS assessed at 12 weeks

    12 weeks

  • Overall survival (OS)

    36 months

Study Arms (1)

Ribociclib

EXPERIMENTAL

Oral, ribociclib 600 mg x 1 a day, 21 days on 7 days off

Drug: Ribociclib

Interventions

RibociclibDRUG

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

Also known as: LEE011
Ribociclib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Age ≥ 18 years
  • Histological confirmed diagnosis of WDL/DDL with metastatic or locally advanced disease not amenable to complete resection
  • WDL/DDL patients must have documentation of disease progression within 6 months prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Measurable disease by RECIST v1.1 criteria. At least one measurable lesion located outside of a previously irradiated area
  • Formalin fixed paraffin embedded tumor blocs and representative hematoxylin/eosin slides (preferably both) should be provided for immunohistochemistry staining and molecular analysis of 50 gene signature panel and must have increased CDK4 gene copy number (at least \>/=3) and proficient Rb gene
  • Patient has adequate bone marrow and organ function
  • Must be able to swallow ribociclib capsules/tablets

You may not qualify if:

  • A known hypersensitivity to ribociclib or any of its excipients
  • A concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
  • Patients with central nervous system (CNS) involvement at least 4 weeks from prior therapy completion
  • Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening)
  • On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \>450 msec
  • Participation in a prior investigational study within 30 days prior to enrollment
  • Patient has had major surgery within 14 days prior to starting study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Be’er Ya‘aqov, 70300, Israel

RECRUITING

MeSH Terms

Conditions

LiposarcomaLipomaLiposarcoma, MyxoidSarcoma

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Daniela Katz, M.D

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Katz, M.D

CONTACT

97289778144katzd@asaf.health.gov.il

Sharona Ben Ami

CONTACT

97289778003sharonab@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

November 29, 2016

First Posted

March 30, 2017

Study Start

July 1, 2016

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)