Clinical trial · Interventional
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma
A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma
NCT02343172CI-TRIAL-00048751completedPhase 1ClinicalTrials.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)
To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.
Conditions
Conditions (1)
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 | Liposarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDM201 | Drug | — | UNRESOLVED |
| LEE011 | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDM201+LEE011
- interventionNames
- Drug: HDM201
- Drug: LEE011
Primary outcomes (3)
- measure
- Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment.
- timeFrame
- 5 years
- description
- DLTs in the first cycle of treatment.
- measure
- Phase Ib: Exposure to HDM201 and LEE011 as measured by AUC 0-24h
- timeFrame
- 5 years
- description
- as measured by AUC0-24h
- measure
- Phase II: Progression free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy * Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment * ECOG performance status of 0-1 Exclusion Criteria: * Prior treatment with compounds with the same mode of action * Patients with TP53 mutated tumors, if the molecular status is known * Symptomatic central nervous system metastases * Inadequate organ function * Previous and concomitant therapy that precludes enrollment, as defined by protocol Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.