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. (see Contacts and Locations)
Verified January 2013 by MolMed S.p.A.
Sponsor:
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

May 19, 2011
January 28, 2013
March 2011
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01358084 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma
NGR019: Randomized Double-blind Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (MPM)

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Malignant Pleural Mesothelioma
  • 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
  • Experimental: Arm A: NGR-hTNF + Best Supportive Care
    Interventions:
    • Drug: NGR-hTNF
    • Other: Best Supportive Care
  • Placebo Comparator: Arm B: Placebo + Best Supportive Care
    Interventions:
    • Drug: Placebo
    • Other: Best Supportive Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Armando Santoro, MD 0
Italy
 
NCT01358084
NGR019, 2010-023614-31
No
MolMed S.p.A.
MolMed S.p.A.
Not Provided
Study Director: Antonio Lambiase, MD MolMed S.p.A.
MolMed S.p.A.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP