metastatic pancreatic adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10051971
Conditions
Interventions
Trade Name: YONDELIS*EV 1FL POLV 0,25MG
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Trabectedin
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. conferma istologica e citologica di diagnosi di adenocarcinoma pancreatico 2. tumore pancreatico metastatico (stadio IV) progredito dopo chemioterapia di prima linea a base di gemcitabina 3. Eta` >_ 18 e = 75 anni 4. Karnofsky performance status> 50 5. malattia misurabile secondo i criteri RECIST 6. Adeguate funzionalita` midollo osseo, epatica e renale 7. Consenso informato scritto 8. adeguati metodi contraccettivi per il/la paziente e partner del paziente Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous second line chemotherapy 2. Concurrent treatment with other experimental drugs 3. Symptomatic brain metastasis 4. Severe comorbidities (e.g. cardiac diseases, history of psychiatric disabilities) 5. Prior or cuncurrent malignancies at other sites with the exeption of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease at least from 5 years 6. Pregnancy or lactation. 7. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the therapeutic activity of trabectedin in terms of progression-free survival rate at 6 months from treatment start in patients with metastatic pancreatic adenocarcinoma.;Secondary Objective: overall survival rate and duration of response, time to treatment failure, toxicity of treatment, biological factors predictive of response and to characterize the impact of pharmacogenomics on pharmacokinetics and antitumor activity.;Primary end point(s): x | — |
Countries
Italy
Outcome results
None listed