Pharmacometabolomic of Trabectedin in Soft Tissue Patients

NCT04394728 | Completed DMC FDA Drug

• 1 other identifier: CRO-2015-04
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

soft tissues sarcoma

Outcome Measures

Primary Outcomes (3)

• Area Under Curve (AUC)

  Pharmacokinetics profile of Trabectedin for 24 hours intravenous infusion

  0-48 hours

• Cmax

  Maximum plasma concentration of Trabectedin

  0-48 hours

• Metabolomics profile

  Predose metabolomic profile in serum and urine

  0 hours ( pre-dose)

Secondary Outcomes (3)

• Progression free survival

  2 years

• Overall survival

  2 years

• Treatment Toxicity

  through study completion, an average of 1 year

Interventions

Trabectedin DRUG

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.

Also known as: Yondelis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Soft tissue sarcoma patients with unresectable and/or metastatic disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Related Links

• Pharmaco-metabolomics: An Emerging "Omics" Tool for the Personalization of Anticancer Treatments and Identification of New Valuable Therapeutic Targets

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gianmaria Miolo

  Centro di Riferimento Oncologico - Aviano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 19, 2020
• Study Start: April 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share