CompletedPhase 3NCT01098266

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

Checked against the public recordLast updated Sep 17, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations49
SponsorAGC Biologics S.p.A.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AGC Biologics S.p.A.
Interventions being studied
Drug: NGR-hTNF plus Best Investigator's Choice (BIC); Drug: Placebo plus Best Investigator's Choice (BIC)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: * Age ≥ 18 years * Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown * Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin * ECOG Performance Status 0 - 2 * Life expectancy of ≥ 12 weeks * Adequate baseline bone marrow, hepatic and renal function, defined as follows: 1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL 2. Bilirubin ≤ 1.5 x ULN 3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis 4. Serum creatinine \< 1.5 x ULN * Measurable or non-measurable disease according to MPM-modified RECIST criteria * Patients may have had prior therapy providing the following conditions are met: 1. Surgery: wash-out period of 14 days 2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days * Patients must give written informed consent to participate in the study 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 CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke) * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Wilshire Oncology Medical GroupCorona, California
  • City of Hope-Comprehensive Cancer CenteDuarte, California
  • H. Lee Moffitt ancer Center and Research InstituteTampa, Florida
  • Johns HopkinsBaltimore, Maryland
  • Columbia UniversityNew York, New York
  • University of PennsylvaniaPhiladelphia, Pennsylvania
  • UTsouthwestern medical centerDallas, Texas
  • Antwerp University HospitalEdegem, Antwerp
  • Centre Hospitalier Universitaire de LiègeLiège, Liege
  • Institut Jules BordetBrussels
  • Cliniques Universitarie St. LucBrussels
  • Universitair ZiekenhuisGhent

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2019. Always confirm current availability with the study team.

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