Clinical trial · Observational
Pharmacometabolomic of Trabectedin in Soft Tissue Patients
Research of Serum and Urine Metabolomic Biomarkers Predictive Pharmacokinetic Parameters of Trabectidin in Patients With Soft Tissues Sarcomas
NCT04394728CI-TRIAL-00045142Metabol-STScompletedClinicalTrials.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)
This perspective, mono institutional study is addressed to find potential serum and urine biomarkers predictive of the pharmacokinetic and pharmacodynamic profile of soft tissue sarcomas patients treated with trabectedin.
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 |
|---|---|---|---|
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Area Under Curve (AUC)
- timeFrame
- 0-48 hours
- description
- Pharmacokinetics profile of Trabectedin for 24 hours intravenous infusion
- measure
- Cmax
- timeFrame
- 0-48 hours
- description
- Maximum plasma concentration of Trabectedin
- measure
- Metabolomics profile
- timeFrame
- 0 hours ( pre-dose)
- description
- Predose metabolomic profile in serum and urine
Secondary outcomes (3)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced Soft Tissues Sarcoma STSs (unresectable and/or metastatic disease). * One previous systemic treatment with ananthracycline ± ifosfamide. * Measurable disease, as defined by RECIST criteria. * ECOG PS ≤2. * Age ≥18 years. * A minimum of 3 weeks since prior tumor directed therapy * Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower. * Adequate haematological, renal liver function. * Ability and willingness to provide informed consent Exclusion Criteria: * Pregnant or breast-feeding women * Prior exposure to Trabectedin. * Peripheral neuropathy, Grade 2 or higher. * Known CNS metastases. * Active viral hepatitis or chronic liver disease. * Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias. * Active major infection. * Other serious concomitant illnesses.
References
Publications (0)
Data not yet available
No reference posted for this study.