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

Study summary

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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNGR-hTNF plus Best Investigator's Choice (BIC) and Placebo plus Best Investigator's Choice (BIC)

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?49 U.S. locations

Locations may change over time.

Who runs it?AGC Biologics S.p.A.

Study sponsor

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)

Explore related studies

How this study is categorized

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

Cancer type

Mesothelioma→

Treatment approach

Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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.

View original record ↗