Salvage therapy with trabectidin in metastatic pancreatic adenocarcinoma: a single-arm phase II trial. - ND

Conditions: metastatic pancreatic adenocarcinoma
MedDRA version: 9.1Level: LLTClassification code 10051971

Registration Number: EUCTR2010-024287-17-IT

Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures