A research study to evaluate the activity of the drug trabectedin in patients with a lung cancer called mesothelioma

Phase 1

• Conditions: Malignant Pleural Mesothelioma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006330-16-IT
• Lead Sponsor: Istituto di ricerche farmacologiche Mario Negri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-26
• Study Completion: 2019-12-09
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 145

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 <30% of bone marrow was irradiated and normal hematological function was completely regained.
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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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.

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 activity of trabectedin in patients with epithelial MPM relapsing after treatment with pemetrexed plus platinum-based drugs<br>;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.<br>To assess the tolerability and safety of trabectedin treatment. <br>To explore the activity of trabectedin with respect to some biological features of MPM<br>;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Progression free survival (PFS), <br>objective response rate <br>overall survival (OS). <br>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. . <br>;Timepoint(s) of evaluation of this end point: 24 months