NGR019: Randomized Double-blind Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (MPM)
18 Years
N/A
Both
Advanced Malignant Pleural Mesothelioma
Trial Information
NGR019: Randomized Double-blind Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (MPM)
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.
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.
Type of Study:
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
Outcome Measure:
Progression-Free Survival (PFS)
Outcome Description:
Defined as the time from the date of randomization until disease progression, or death
Outcome Time Frame:
every 6 weeks
Safety Issue:
No
Principal Investigator
Antonio Lambiase, MD
Investigator Role:
Study Director
Investigator Affiliation:
MolMed S.p.A.
Authority:
Italy: Ethics Committee
Study ID:
NGR019
NCT ID:
NCT01358084
Start Date:
March 2011
Completion Date:
June 2013
Related Keywords:
- Advanced Malignant Pleural Mesothelioma
- Malignant Pleural Mesothelioma
- MPM
- Maintenance treatment
- NGR-hTNF
- Mesothelioma
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