Clinical trial · Interventional
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
- 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 multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin | Drug | Doxorubicin | ALIAS |
| RO5045337 | Drug | RG7112 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: RO5045337
- Drug: doxorubicin
Primary outcomes (2)
- measure
- Maximum tolerated dose/dose-limiting toxicities
- timeFrame
- approximately 12 months
- measure
- Safety: Incidence of adverse events
- timeFrame
- approximately 12 months
Secondary outcomes (2)
- measure
- Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed soft tissue sarcoma * Evaluable disease according to RECIST version 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Eligible for doxorubicin therapy * Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade \</= 1 prior to start of study * Adequate bone marrow, hepatic and renal function * Patients with stable CNS metastases are eligible Exclusion Criteria: * Previous treatment with limiting doses of doxorubicin * Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment \</= 28 days from Day 1 dosing on study treatment * History of seizure disorders or unstable CNS metastases * Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study * Pregnant or breastfeeding women * HIV positive patients who are currently receiving combination anti-retroviral therapy * Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia * Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
References
Publications (0)
Data not yet available