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

NCT01358084 | Completed Phase 2

• 2 other identifiers: NGR0192010-023614-31
• Study Type: interventional
• Target: 137
• Locations: 3 countries
• Sites: 15

Brief Summary

The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma

Conditions

Advanced Malignant Pleural Mesothelioma

Keywords

Malignant Pleural Mesothelioma; MPM; Maintenance treatment; NGR-hTNF

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Defined as the time from the date of randomization until disease progression, or death

  every 6 weeks

Secondary Outcomes (4)

• Overall survival (OS)

  every 6-12 weeks

• Tumor response

  every 6 weeks

• Safety and Toxicity according to NCI-CTCAE criteria(version 4.03)

  during the study

• Quality of life assessment by using a questionnaire according to Lung Cancer Symptom Scale (LCSS)

  From date of randomization until the end of treatment, assessed every 6 weeks

Study Arms (2)

Arm A: NGR-hTNF + Best Supportive Care

EXPERIMENTAL

NGR-hTNF + Best Supportive Care

Drug: NGR-hTNF; Other: Best Supportive Care

Arm B: Placebo + Best Supportive Care

PLACEBO COMPARATOR

Placebo + Best Supportive Care

Drug: Placebo; Other: Best Supportive Care

Interventions

NGR-hTNF DRUG

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

Arm A: NGR-hTNF + Best Supportive Care

Placebo DRUG

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

Arm B: Placebo + Best Supportive Care

Best Supportive Care OTHER

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

Arm A: NGR-hTNF + Best Supportive Care; Arm B: Placebo + Best Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Patients with non-progressive disease after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease
• ECOG Performance Status 0 - 1
• Life expectancy of ≥ 12 weeks
• Adequate baseline bone marrow, hepatic and renal function, defined as follows:
• Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x109/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 malignant pleural mesothelioma-modified RECIST criteria
• Patients may have had prior therapy providing the following conditions are met:
• Surgery: wash-out period of 14 days
• Radiation therapy: wash-out period of 28 days
• Chemotherapy: wash-out period of 21 days

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 Central Nervous System disease unless adequately treated
• 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.

Sponsors & Collaborators

• AGC Biologics S.p.A.: lead

Study Sites (15)

Zentralklinik Bad Berka GmbH

Bad Berka, Thuringia, 99437, Germany

Location

Asklepios Fachkliniken München-Gauting

München-Gauting, 82131, Germany

Location

Ospedale Santo Spirito

Casale Monferrato, Alessandria, 15033, Italy

Location

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

Meldola, Forlì-Cesena, 47014, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

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

Alessandria, 15121, Italy

Location

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

Genoa, 16132, Italy

Location

Asl 3 genovese, Ospedale Villa Scassi

Genova, 16149, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

Location

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Azienda Unità Sanitaria locale di Ravenna

Ravenna, 48121, Italy

Location

Ospedale Ca' Foncello

Treviso, 31100, Italy

Location

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

Saint Petersburg, 197089, Russia

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Antonio Lambiase, MD

  AGC Biologics S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: March 1, 2011
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

DE (2); IT (12); RU (1)