NCT02571829

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 May 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

October 6, 2015

Last Update Submit

November 22, 2016

Conditions

LiposarcomaSoft Tissue Sarcoma

Keywords

LiposarcomaSoft tissue sarcomaCDK4CDK6LEE011ribociclib

Outcome Measures

Primary Outcomes (1)

  • Response to therapy as evaluated by RECIST 1.1 and Choi

    36 months (24 months accrual period and 12 month follow up period)

Secondary Outcomes (3)

  • Median PFS and PFS assessed at 12 weeks (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.

    12 weeks

  • Overall survival (OS) 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.

    36 months (24 months accrual period and 12 month follow up period)

  • Evaluate the time from first documented response to disease progression

    36 months (24 months accrual period and 12 month follow up period)

Study Arms (1)

ribociclib

EXPERIMENTAL

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

Drug: ribociclib

Interventions

ribociclibDRUG

Oral, 600 mg x 1 a day, duration - according to response

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)

Hadassah Medical Organization

Jerusalem, 991120, Israel

Location

Related Publications (5)

  • Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol. 2006 Apr 10;24(11):1770-83. doi: 10.1200/JCO.2005.03.7689.

    PMID: 16603719BACKGROUND

  • Ortega S, Malumbres M, Barbacid M. Cyclin D-dependent kinases, INK4 inhibitors and cancer. Biochim Biophys Acta. 2002 Mar 14;1602(1):73-87. doi: 10.1016/s0304-419x(02)00037-9.

    PMID: 11960696BACKGROUND

  • Barretina J, Taylor BS, Banerji S, Ramos AH, Lagos-Quintana M, Decarolis PL, Shah K, Socci ND, Weir BA, Ho A, Chiang DY, Reva B, Mermel CH, Getz G, Antipin Y, Beroukhim R, Major JE, Hatton C, Nicoletti R, Hanna M, Sharpe T, Fennell TJ, Cibulskis K, Onofrio RC, Saito T, Shukla N, Lau C, Nelander S, Silver SJ, Sougnez C, Viale A, Winckler W, Maki RG, Garraway LA, Lash A, Greulich H, Root DE, Sellers WR, Schwartz GK, Antonescu CR, Lander ES, Varmus HE, Ladanyi M, Sander C, Meyerson M, Singer S. Subtype-specific genomic alterations define new targets for soft-tissue sarcoma therapy. Nat Genet. 2010 Aug;42(8):715-21. doi: 10.1038/ng.619. Epub 2010 Jul 4.

    PMID: 20601955BACKGROUND

  • Dickson MA, Tap WD, Keohan ML, D'Angelo SP, Gounder MM, Antonescu CR, Landa J, Qin LX, Rathbone DD, Condy MM, Ustoyev Y, Crago AM, Singer S, Schwartz GK. Phase II trial of the CDK4 inhibitor PD0332991 in patients with advanced CDK4-amplified well-differentiated or dedifferentiated liposarcoma. J Clin Oncol. 2013 Jun 1;31(16):2024-8. doi: 10.1200/JCO.2012.46.5476. Epub 2013 Apr 8.

    PMID: 23569312BACKGROUND

  • Van Glabbeke M, Verweij J, Judson I, Nielsen OS; EORTC Soft Tissue and Bone Sarcoma Group. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer. 2002 Mar;38(4):543-9. doi: 10.1016/s0959-8049(01)00398-7.

    PMID: 11872347BACKGROUND

MeSH Terms

Conditions

LiposarcomaSarcoma

Interventions

ribociclib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniela Katz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

IL(1)