NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

Completed · Phase 3 · Has a placebo group

Conditions studied: Malignant Pleural Mesothelioma

In brief

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.

Key facts

Study ID

NCT01098266

Run by

AGC Biologics S.p.A.

People needed

400

Starts

2010-04-12

Expected to finish

2017-12-01

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
• Bilirubin ≤ 1.5 x ULN
• AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
• 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:
• Surgery: wash-out period of 14 days
• Systemic and radiation anti-tumor therapy: wash-out period of 28 days
• Patients must give written informed consent to participate in the study

You may not qualify if…

• 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

Where it is running

• Wilshire Oncology Medical Group — Corona, California, United States
• City of Hope-Comprehensive Cancer Cente — Duarte, California, United States
• H. Lee Moffitt ancer Center and Research Institute — Tampa, Florida, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Columbia University — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UTsouthwestern medical center — Dallas, Texas, United States
• Antwerp University Hospital — Edegem, Antwerp, Belgium
• Centre Hospitalier Universitaire de Liège — Liège, Liege, Belgium
• Institut Jules Bordet — Brussels, Belgium
• Cliniques Universitarie St. Luc — Brussels, Belgium
• Universitair Ziekenhuis — Ghent, Belgium
• UAB - Alberta Cancer Board - Cross Cancer Institute — Edmonton, Alberta, Canada
• University Health Network, Princess Margaret Hospital — Toronto, Ontario, Canada
• National Cancer Institute — Cairo, Egypt
• Hôpitaux de Marseille Hôpital Nord — Marseille, France
• St James's Hospital — Dublin, Ireland
• Ospedale Santo Spirito — Casale Monferrato, Alessandria, Italy
• Azienda Ospedaliera Universitaria San Luigi Gonzaga — Orbassano, Torino, Italy
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria — Alessandria, Italy
• Centro di Riferimento Oncologico — Aviano, Italy
• Ospedale Valduce — Como, Italy
• Azienda Ospedaliero-Universitaria Careggi di Firenze — Florence, Italy
• Istituto Nazionale per la Ricerca sul Cancro — Genoa, Italy
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST — Meldola, Italy

Full record on ClinicalTrials.gov

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