Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM

PHASE2CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

December 5, 2018

Study Completion Date

December 5, 2018

Conditions
Advanced Malignant Pleural Mesothelioma
Interventions
DRUG

NGR-hTNF

NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

DRUG

Placebo

Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

OTHER

Best Supportive Care

Where applicable and as appropriate according to Institutional clinical practice and literature guidelines. Best supportive care includes antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis

Trial Locations (15)

15033

Ospedale Santo Spirito, Casale Monferrato

15121

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria

16132

IRCCS Azienda Ospedaliera Universitaria San Martino IST Istituto Nazionale per la Ricerca sul Cancro, Genoa

16149

Asl 3 genovese, Ospedale Villa Scassi, Genova

20089

Istituto Clinico Humanitas, Rozzano

20132

IRCCS Ospedale San Raffaele, Milan

27100

IRCCS Policlinico S. Matteo, Pavia

31100

Ospedale Ca' Foncello, Treviso

35128

Istituto Oncologico Veneto, Padua

43126

Azienda Ospedaliero-Universitaria di Parma, Parma

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Meldola

48121

Azienda Unità Sanitaria locale di Ravenna, Ravenna

82131

Asklepios Fachkliniken München-Gauting, München-Gauting

99437

Zentralklinik Bad Berka GmbH, Bad Berka

197089

Saint Petersburg State Medical University n.a. I. P. Pavlov, Saint Petersburg

Sponsors
All Listed Sponsors
lead

AGC Biologics S.p.A.

INDUSTRY