Clinical trial · Interventional
A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma
A Phase II Single Arm Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma
NCT03096912CI-TRIAL-00030036unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liposarcoma; Mixed Type | — | UNRESOLVED | — |
| Liposarcomas, Dedifferentiated | Liposarcoma | ALIAS | 0.85 |
| Liposarcoma - Well Differentiated | Atypical Lipomatous Tumor/Well Differentiated Liposarcoma | ALIAS | 0.90 |
| Soft-Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ribociclib
- description
- Oral, ribociclib 600 mg x 1 a day, 21 days on 7 days off
- interventionNames
- Drug: Ribociclib
Primary outcomes (2)
- measure
- Response to therapy as evaluated by RECIST 1.1
- timeFrame
- 36 months
- measure
- Response to therapy as evaluated by Choi
- timeFrame
- 36 months
Secondary outcomes (3)
- measure
- Median PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.