Clinical trial · Interventional
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
- 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)
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.
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 |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO5045337 | Drug | RG7112 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: RO5045337
Primary outcomes (1)
- measure
- Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
- timeFrame
- from baseline to week 12
Secondary outcomes (3)
- measure
- Safety and tolerability: Adverse events, laboratory parameters, ECG
- timeFrame
- up to approximately 4 months after study start
- measure
- Tumor response according to RECIST criteria assessed by CT or MRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>/=18 years of age * well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery * willing to undergo tumor biopsies before, during and after treatment * ECOG performance status 0-1 Exclusion Criteria: * previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable * patients receiving any other agent or therapy to treat their malignancy * patients requiring anticoagulant therapy and/or anti-platelet therapy * pre-existing gastrointestinal disorders which may interfere with absorption of drugs * history of seizure disorders or unstable CNS metastases * clinically significant cardiovascular disease * history of long QT syndrome
References
Publications (0)
Data not yet available