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

2014-08-27 03:14:46 | BioPortfolio

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.

Description

Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen.

For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting.

However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice.

Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting.

The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Malignant Pleural Mesothelioma

Intervention

NGR-hTNF plus Best Investigator Choice (BIC), Placebo plus Best Investigator Choice (BIC)

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano
Torino
Italy
10043

Status

Recruiting

Source

MolMed S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:46-0400

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PubMed Articles [2654 Associated PubMed Articles listed on BioPortfolio]

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Editorial: New Investigator Review Awards The 2018 New Investigator Awards.

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Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Laws requiring patients under managed care programs to receive services from the physician or other provider of their choice. Any willing provider laws take many different forms, but they typically prohibit managed-care organizations from having a closed panel of physicians, hospitals, or other providers.

The Balanced Budget Act (BBA) of 1997 establishes a Medicare+Choice program under part C of Title XVIII, Section 4001, of the Social Security Act. Under this program, an eligible individual may elect to receive Medicare benefits through enrollment in a Medicare+Choice plan. Beneficiaries may choose to use private pay options, establish medical savings accounts, use managed care plans, or join provider-sponsored plans.

Expectation of real uncertainty on the part of the investigator regarding the comparative therapeutic merits of each arm in a trial.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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