Malignant Pleural Mesothelioma
Conditions
Interventions
Trade Name: Yondelis
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRABECTEDIN
CAS Number: 114899-77-3
Concentration unit: mg/m2 milligram(s)/square meter
Sponsors
Istituto di ricerche farmacologiche "Mario Negri"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cytological or histological diagnosis of unresectable MPM; age >18 years; Performance status 0-2 (ECOG); measurable disease (CT-PET); normal bone marrow reserve; adequate liver and renal function; not more than one previous chemotherapy course (of pemetrexed plus platinum derivative); previous chemotherapy course concluded at least 3 weeks prior to recruitment; atients must have recovered from toxicities of prior treatment (grade = 1), life expectancy >3 months; written informed consent; negative pregnancy test. Patients who have received palliative radiation are eligible if =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy); adjuvant chemotherapy; severe concomitant illness; uncompensated diabetes mellitus or other condition absolutely contra-indicating dexamethasone (20 mg, used as pre-medication); enrollment in other trials; pregnant or breast-feeding women; prior exposure to trabectedin; history of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse; 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; Brain / leptomeningeal involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of trabectedin in patients with epithelial MPM relapsing after treatment with pemetrexed plus platinum-based drugs ;Secondary Objective: To assess the activity of trabectedin in patients with biphasic or sarcomatoid either as first line treatment or following a previous course of platinum derivates and pemetrexed. To assess the tolerability and safety of trabectedin treatment. To explore the activity of trabectedin with respect to some biological features of MPM ;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS), objective response rate overall survival (OS). Safety will be evaluated based on reported AEs, clinical laboratory assessments, vital signs and physical examinations. Adverse events will be encoded using the Medical Dictionary for Regulatory Activities (MedDRA?) and graded using NCI-CTCAE ver 4. . ;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactLital Hollander
Istituto di ricerche farmacologiche "Mario Negri"
Outcome results
None listed