Mesothelioma.com Resources for Patients and their Families

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

Brief 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.

Tracking Information
First Received DateMarch 17, 2010
Last Changed DateOctober 8, 2015
Start DateMarch 2010
Anticipated Primary Completion DateDecember 2016
Primary Outcome Measures

Overall Survival (OS) [Time Frame: every 6-12 weeks]

Secondary Outcome Measures

Progression-Free Survival (PFS) [Time Frame: every 6-12 weeks]

Disease Control Rate (DCR) [Time Frame: every 6-12 weeks]

Duration of Disease Control [Time Frame: every 6-12 weeks]

Safety and Toxicity according to NCI-CTCAE criteria (version 4.02) [Time Frame: every 6-12 weeks]

Quality of life (QoL) according to Lung Cancer Symptom Scale [Time Frame: every 6-12 weeks]

Evaluation of medical care utilization in the two treatment arms [Time Frame: every 6-12 weeks]

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Drug: NGR-hTNF plus Best Investigator's Choice (BIC)
  • Drug: Placebo plus Best Investigator's Choice (BIC)
Study Arms / Comparison Groups2 / 0
Detailed 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.

Recruitment Information
Recruitment StatusActive, not recruiting
Anticipated Enrollment390
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT01098266
Responsible Party,
SponsorMolMed S.p.A.
Verification DateOctober 2015
Mesothelioma Doctors by State
  • Breaking News
  • Emerging Clinical Trials
  • Delivered within 24 hrs

Yes   No

Mesothelioma Cancer Alliance Blog

FEATURED CONTENT:


RECENT POSTS:

Surviving Peritoneal Mesothelioma: Stephen Jay Gould’s Cancer Journey

Understanding Cancer Clinical Trials

Quest for a Cure: MCA Supports Cancer Research Month

Mesothelioma Treatment Guide

Free Mesothelioma Treatment Guide

Please fill in the form below to request our FREE Mesothelioma Treatment Guide. It will be sent to you within 24 hours.

Have you or someone you know been diagnosed with mesothelioma?

Get Access To: