Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (NGR019)
This study is currently recruiting participants.
Verified January 2013 by MolMed S.p.A.
Sponsor:
MolMed S.p.A.
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT01358084
First received: May 19, 2011
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Malignant Pleural Mesothelioma |
Drug: NGR-hTNF Drug: Placebo Other: Best Supportive Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | NGR019: Randomized Double-blind Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (MPM) |
Resource links provided by NLM:
Further study details as provided by MolMed S.p.A.:
Primary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]Defined as the time from the date of randomization until disease progression, or death
Secondary Outcome Measures:
- Overall survival (OS) [ Time Frame: every 6-12 weeks ] [ Designated as safety issue: No ]Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
- Tumor response [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]Assessed according to modified RECIST criteria for MPM
- Safety and Toxicity according to NCI-CTCAE criteria(version 4.03) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- Quality of life (QoL) according to Lung Cancer Symptom Scale [ Time Frame: every 6-12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A: NGR-hTNF + Best Supportive Care |
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
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
|
| Placebo Comparator: Arm B: Placebo + Best Supportive Care |
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
|
Detailed Description:
First-line treatment of advanced malignant pleural mesothelioma (MPM) is based on six cycles of a pemetrexed-based chemotherapy, with a median progression-free survival (PFS) of approximately 6 months.However, the median time from completion of first-line treatment to initiation of second-line therapy is approximately 3 months. Recent experiences in non-small cell lung cancer patients have shown that a maintenance treatment given immediately after first-line treatment regimens can improve PFS and survival. Considering the toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms registered in a phase II trial in previously treated MPM patients, as well as the disease control observed in about half of the patients and maintained for more than four months and more than nine months in the triweekly and weekly cohorts, respectively, seems justified to compare in a randomized phase II trial the time-related efficacy of NGR-hTNF against placebo in advanced MPM patients who did not progress after six cycles of a standard pemetrexed-based treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Good clinical conditions
- Adequate baseline bone marrow, hepatic and renal function
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358084
Contacts
| Contact: Armando Santoro, MD | 0 |
Locations
| Italy | |
| Ospedale Santo Spirito | Recruiting |
| Casale Monferrato, Alessandria, Italy, 15033 | |
| Contact: Mario Botta, MD | |
| Principal Investigator: Mario Botta, MD | |
| Istituto Clinico Humanitas | Recruiting |
| Rozzano, Milan, Italy, 20089 | |
| Principal Investigator: Armando Santoro, MD | |
| Sub-Investigator: Paolo Zucali, MD | |
| Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria | Recruiting |
| Alessandria, Italy, 15121 | |
| Contact: Federica Grosso, MD | |
| Principal Investigator: Federica Grosso, MD | |
| IRCCS Azienda Ospedaliera Universitaria San Martino IST Istituto Nazionale per la Ricerca sul Cancro | Not yet recruiting |
| Genoa, Italy, 16132 | |
| Contact: Francesco Grossi, MD | |
| Principal Investigator: Francesco Grossi, MD | |
| Asl 3 genovese, Ospedale Villa Scassi | Recruiting |
| Genova, Italy, 16149 | |
| Contact: Manlio Mencoboni, MD | |
| Principal Investigator: Manlio Mencoboni, MD | |
| Azienda Ospedaliero-Universitaria di Parma | Not yet recruiting |
| Parma, Italy, 43126 | |
| Contact: Marcello Tiseo, MD | |
| Principal Investigator: Marcello Tiseo, MD | |
| IRCCS Policlinico S. Matteo | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: Camillo Porta, MD | |
| Principal Investigator: Camillo Porta, MD | |
| Ospedale Ca' Foncello | Recruiting |
| Treviso, Italy, 31100 | |
| Contact: Giovanni Rosti, MD | |
| Principal Investigator: Giovanni Rosti, MD | |
Sponsors and Collaborators
MolMed S.p.A.
Investigators
| Study Director: | Antonio Lambiase, MD | MolMed S.p.A. |
More Information
No publications provided
| Responsible Party: | MolMed S.p.A. |
| ClinicalTrials.gov Identifier: | NCT01358084 History of Changes |
| Other Study ID Numbers: | NGR019, 2010-023614-31 |
| Study First Received: | May 19, 2011 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by MolMed S.p.A.:
|
Malignant Pleural Mesothelioma MPM Maintenance treatment NGR-hTNF |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
ClinicalTrials.gov processed this record on May 22, 2013