The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
|First Received Date||March 17, 2010|
|Last Changed Date||October 8, 2015|
|Start Date||March 2010|
|Anticipated Primary Completion Date||December 2016|
|Primary Outcome Measures||
Overall Survival (OS) [Time Frame: every 6-12 weeks]
|Secondary Outcome Measures||
Progression-Free Survival (PFS) [Time Frame: every 6-12 weeks]
Disease Control Rate (DCR) [Time Frame: every 6-12 weeks]
Duration of Disease Control [Time Frame: every 6-12 weeks]
Safety and Toxicity according to NCI-CTCAE criteria (version 4.02) [Time Frame: every 6-12 weeks]
Quality of life (QoL) according to Lung Cancer Symptom Scale [Time Frame: every 6-12 weeks]
Evaluation of medical care utilization in the two treatment arms [Time Frame: every 6-12 weeks]
|Study Arms / Comparison Groups||2 / 0|
Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen.
For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting.
However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice.
Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting.
The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.
|Recruitment Status||Unknown status|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- Age ≥ 18 years
- Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
- Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin
- ECOG Performance Status 0 - 2
- Life expectancy of ≥ 12 weeks
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
2. Bilirubin ≤ 1.5 x ULN
3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
4. Serum creatinine < 1.5 x ULN
- Measurable or non-measurable disease according to MPM-modified RECIST criteria
- Patients may have had prior therapy providing the following conditions are met:
1. Surgery: wash-out period of 14 days
2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days
- Patients must give written informed consent to participate in the study
- Patients must not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension
- QTc interval (congenital or acquired) > 450 ms
- History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
- Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
- Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
- Pregnancy or lactation
|Verification Date||October 2015|