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Liposarcomas, DedifferentiatedPhase 2NCT03096912

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

A Phase 2 study testing Ribociclib in people with Liposarcomas, Dedifferentiated and Liposarcoma - Well Differentiated, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ribociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIsrael
Study dates
Jul 2016to Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Daniela Katz, M.D contact

97289778144

katzd@asaf.health.gov.il

Sharona Ben Ami contact

97289778003

sharonab@asaf.health.gov.il

Israel1 site, 1 recruiting

  • Assaf Harofeh Medical Center

    Be’er Ya‘aqov, 70300

    Daniela Katz, MD, 97289778144, katzd@asaf.health.gov.il

    Sharona Ben Ami, 97289778003, sharonab@asaf.health.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: A Phase II Single Arm Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma

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

Read the detailed description

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.

Being tested
Ribociclib
Keywords
CDK4 inhibitor, LEE011, ribociclib, liposarcoma dedifferentiated, liposarcoma well differentiated
Medical subject headings
Liposarcoma, Lipoma, Liposarcoma, Myxoid, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibDrug

    Also called LEE011

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

Study groups in NCT03096912
Study groupRoleWhat they receive
RibociclibExperimentalOral, ribociclib 600 mg x 1 a day, 21 days on 7 days off
Receives: Drug: Ribociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to therapy as evaluated by RECIST 1.1

    Measured: 36 months

  2. Response to therapy as evaluated by Choi

    Measured: 36 months

Secondary outcomes (3)

  1. Median PFS

    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.

    Measured: 36 months

  2. PFS assessed at 12 weeks

    Number of total patients who are PFS at 12 weeks of treatment

    Measured: 12 weeks

  3. 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

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study startJul 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionApr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096912
Sponsor's protocol ID
243/16
Status last verified
Oct 2017
First submitted
29 Nov 2016
Last updated
25 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribociclib in people with Liposarcomas, Dedifferentiated and Liposarcoma - Well Differentiated, run by Assaf-Harofeh Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniela Katz, M.D (97289778144, katzd@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to therapy as evaluated by RECIST 1.1 (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.

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