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History of Changes for Study: NCT01098266
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Latest version (submitted August 28, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 1, 2010 None (earliest Version on record)
2 October 29, 2010 Contacts/Locations, Study Status and Oversight
3 May 30, 2011 Contacts/Locations and Study Status
4 December 30, 2011 Contacts/Locations, Sponsor/Collaborators and Study Status
5 July 2, 2012 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
6 January 28, 2013 Recruitment Status, Contacts/Locations and Study Status
7 April 1, 2015 Arms and Interventions, Study Status and Contacts/Locations
8 October 8, 2015 Study Status
9 December 20, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design
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Results Submission Events
10 August 28, 2019 Study Status, Outcome Measures and Results
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Study NCT01098266
Submitted Date:  April 1, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: NGR015
Brief Title: NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Official Title: NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
Secondary IDs: 2009-016879-29 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2010
Overall Status: Recruiting
Study Start: March 2010
Primary Completion: February 2013 [Anticipated]
Study Completion: February 2013 [Anticipated]
First Submitted: March 17, 2010
First Submitted that
Met QC Criteria:
April 1, 2010
First Posted: April 2, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 1, 2010
Last Update Posted: April 2, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AGC Biologics S.p.A.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Malignant Pleural Mesothelioma
Keywords: MPM
NGR-hTNF
NGR-hTNF plus BIC
Randomized double-blind phase III study
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 390 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: A: NGR-hTNF + BIC Drug: NGR-hTNF plus Best Investigator Choice (BIC)
  • NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
  • Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
  • Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
    1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
    2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
    3. Vinorelbine: 25-30 mg/m2 iv (or 60-80 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Placebo Comparator: B: Placebo+BIC Drug: Placebo plus Best Investigator Choice (BIC)
  • Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
  • Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
  • Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
    1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
    2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
    3. Vinorelbine: 25-30 mg/m2 iv (or 60-80 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: every 6-12 weeks ]

Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Secondary Outcome Measures:
1. Progression-Free Survival (PFS)
[ Time Frame: every 6-12 weeks ]

Defined as the time from the date of randomization until disease progression, or death
2. Disease Control Rate (DCR)
[ Time Frame: every 6-12 weeks ]

Defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease
3. Duration of Disease Control
[ Time Frame: every 6-12 weeks ]

Measured from the date of randomization until disease progression, or death due to any cause
4. Safety and Toxicity according to NCI-CTCAE criteria (version 4.02)
[ Time Frame: every 6-12 weeks ]

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

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

Medical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • 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 and radiation therapy: wash-out period of 14 days
    2. Systemic 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. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days before the enrolment
Open or close this module Contacts/Locations
Central Contact Person: Federico Caligaris Cappio, MD
Telephone: +39
Study Officials: Antonio Lambiase, MD
Study Director
AGC Biologics S.p.A.
Locations: Italy
Istituto Nazionale per la Ricerca sul Cancro
[Recruiting]
Genoa, Italy, 16132
Contact:Contact: Francesco Grossi, MD
Contact:Principal Investigator: Francesco Grossi, MD
Fondazione San Raffaele del Monte Tabor
[Recruiting]
Milan, Italy, 20132
Contact:Contact: Federico Caligaris Cappio, MD
Contact:Sub-Investigator: Vanesa Gregorc, MD
Italy, Torino
Azienda Ospedaliera Universitaria San Luigi Gonzaga
[Recruiting]
Orbassano, Torino, Italy, 10043
Contact:Contact: Silvia Novello, MD
Contact:Principal Investigator: Silvia Novello, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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