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Pharmacometabolomic of Trabectedin in Soft Tissue Patients

NCT04394728 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2020-05-19

No results posted yet for this study

Summary

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

  • Sarcoma

Interventions

DRUG

Trabectedin

1.3 mg/m2 with a top-dose of 2.6 mg per cycle, via a central venous catheter as a 24-hour infusion every 21 days.All patients received premedication with dexamethasone 20 mg i.v. 30 min before administration of trabectedin.

Sponsors & Collaborators

  • Centro di Riferimento Oncologico - Aviano

    lead OTHER

Principal Investigators

  • Gianmaria Miolo · Centro di Riferimento Oncologico - Aviano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2020-01-31
Completion
2020-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394728 on ClinicalTrials.gov