SarcomaMetabol-STSNCT04394728
Pharmacometabolomic of Trabectedin in Soft Tissue Patients
An observational study of Sarcoma, run by Centro di Riferimento Oncologico - Aviano.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Trabectedin
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Soft tissue sarcoma patients with unresectable and/or metastatic disease
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
About this study
Official title: Research of Serum and Urine Metabolomic Biomarkers Predictive Pharmacokinetic Parameters of Trabectidin in Patients With Soft Tissues Sarcomas
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.
Read the detailed description
This investigation enrolled patients with unresectable and/or metastatic soft tissue sarcoma not responsive to the first-line treatment based on anthracycline/ifosfamide. Patients underwent trabectedin monotherapy that was administered intravenously at the dose of 1.3 mg/m2 every 21 days.
Single overnight fasting urine and blood samples were collected on day-1 of the first trabectedin administration.
Plasma pharmacokinetics was performed during cycle 1. Blood samples, drawn from a site separate from the drug infusion site, were obtained prior to the infusion (basal) at 2, 8, 24 (end of infusion) and 0.5, 1.0, 4.0, 8.0, 24.0 after the end of the infusion. Plasma concentrations of trabectedin were measured by liquid chromatography, tandem mass spectrometry assay (LC-MS/MS) and the pharmacokinetic parameters (Cmax, Clearance, AUC and T1/2) were calculated from the concentration-time curve using a non-compartmental model.
Metabolomics profiles were explored by LC-MS/MS in predose urine and serum and encompassed a total of 192: a) 45 amino acid derivatives, virtually involved in a wide set of biochemical pathways; b) 40 different acylcarnitines, principally involved in the cellular energy metabolism; c) 15 lysophosphatidylcholine metabolites, 77 phosphatidylcholine derivatives, and 15 sphingomyelins, involved in fatty acid metabolism and cellular signaling. The identification of predictive metabolomics biomarkers is performed using univariate and multivariate statistical analyses.
- Conditions
- Sarcoma
- Being tested
- Trabectedin
- Keywords
- soft tissues sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
Also called Yondelis
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Pharmacokinetics profile of Trabectedin for 24 hours intravenous infusion
Measured: 0-48 hours
Cmax
Maximum plasma concentration of Trabectedin
Measured: 0-48 hours
Metabolomics profile
Predose metabolomic profile in serum and urine
Measured: 0 hours ( pre-dose)
Secondary outcomes (3)
Progression free survival
From the first day of treatment to progression or death due to any cause
Measured: 2 years
Overall survival
The time from the first course of trabectedin to death from any cause or to the last follow-up
Measured: 2 years
Treatment Toxicity
Hematologic and non-hematologic toxicity according to WHO
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study startApr 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianmaria Miolo, Principal investigator, Centro di Riferimento Oncologico - Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394728
- Sponsor's protocol ID
- CRO-2015-04
- Acronym
- Metabol-STS
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Serum and Urine Metabolomic Biomarkers Predictive Pharmacokinetic Parameters of Trabectidin in Patients With Soft Tissues Sarcomas
- ClinicalTrials.gov ID
- NCT04394728
- Acronym / sponsor ID
- Metabol-STS / CRO-2015-04
- Conditions
- Sarcoma
- Keywords
- soft tissues sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This investigation enrolled patients with unresectable and/or metastatic soft tissue sarcoma not responsive to the first-line treatment based on anthracycline/ifosfamide. Patients underwent trabectedin monotherapy that was administered intravenously at the dose of 1.3 mg/m2 every 21 days.
Single overnight fasting urine and blood samples were collected on day-1 of the first trabectedin administration.
Plasma pharmacokinetics was performed during cycle 1. Blood samples, drawn from a site separate from the drug infusion site, were obtained prior to the infusion (basal) at 2, 8, 24 (end of infusion) and 0.5, 1.0, 4.0, 8.0, 24.0 after the end of the infusion. Plasma concentrations of trabectedin were measured by liquid chromatography, tandem mass spectrometry assay (LC-MS/MS) and the pharmacokinetic parameters (Cmax, Clearance, AUC and T1/2) were calculated from the concentration-time curve using a non-compartmental model.
Metabolomics profiles were explored by LC-MS/MS in predose urine and serum and encompassed a total of 192: a) 45 amino acid derivatives, virtually involved in a wide set of biochemical pathways; b) 40 different acylcarnitines, principally involved in the cellular energy metabolism; c) 15 lysophosphatidylcholine metabolites, 77 phosphatidylcholine derivatives, and 15 sphingomyelins, involved in fatty acid metabolism and cellular signaling. The identification of predictive metabolomics biomarkers is performed using univariate and multivariate statistical analyses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Soft tissue sarcoma patients with unresectable and/or metastatic disease
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrabectedinAlso: Yondelis1.3 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. | Drug | – |
Primary outcome
Area Under Curve (AUC)
Time frame: 0-48 hours
Pharmacokinetics profile of Trabectedin for 24 hours intravenous infusion
Cmax
Time frame: 0-48 hours
Maximum plasma concentration of Trabectedin
Metabolomics profile
Time frame: 0 hours ( pre-dose)
Predose metabolomic profile in serum and urine
3 secondary outcomes
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Treatment Toxicity
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Pharmaco-metabolomics: An Emerging "Omics" Tool for the Personalization of Anticancer Treatments and Identification of New Valuable Therapeutic TargetsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianmaria Miolo principal investigator
Centro di Riferimento Oncologico - Aviano
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Centro di Riferimento Oncologico - Aviano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) (time frame: 0-48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.