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Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma (NGR010)

Primary Purpose

Malignant Pleural Mesothelioma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
NGR-hTNF
Sponsored by
AGC Biologics S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring NGR-hTNF, malignant pleural mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen
  • Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed
  • Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy
  • ECOG Performance status 0 - 2

  • Adequate baseline bone marrow, hepatic and renal function, defined as follows:

    • Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
    • Bilirubin < 1.5 x ULN
    • AST and/or ALT < 2.5 x ULN in absence of liver metastasis
    • AST and/or ALT < 5 x ULN in presence of liver metastasis
    • Serum creatinine < 1.5 x ULN
  • Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)

  • Patients may have had prior therapy providing the following conditions are met:

    • Chemotherapy and radiotherapy: wash-out period of 28 days
    • Surgery: wash-out period of 14 days
  • Normal cardiac function and absence of uncontrolled hypertension
  • Patients must give written informed consent to participate in the study

Exclusion Criteria:

  • Concurrent anticancer therapy
  • Patients may not receive any other investigational agents while on study
  • Clinical signs of CNS involvement
  • 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 prior to registration

Sites / Locations

  • Istituto Clinico Humanitas
  • Fondazione San Raffaele del Monte Tabor
  • Istituto Europeo Oncologico
  • Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NGR-hTNF

Arm Description

NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly

Outcomes

Primary Outcome Measures

Antitumor activity defined as progression free survival (PFS)
Defined as the time from the date of randomization until disease progression, or death

Secondary Outcome Measures

Tumor Growth Control Rate (TGCR)
Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma
Overall survival (OS)
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
Experimental Imaging Study (DCE-MRI)
To document possible modifications on vessels permeability by imaging techniques
Cmax of NGR-hTNF in patients treated with weekly schedule
to evaluate Cmax of NGR-hTNF administered weekly
AUC(tau) of NGR-hTNF in patients treated with weekly schedule
to evaluate AUC(tau) of NGR-hTNF administered weekly
Safety according to NCI-CTCAE criteria (version 3)
To evaluate safety profile related to NGR-hTNF

Full Information

First Posted
June 7, 2007
Last Updated
January 14, 2019
Sponsor
AGC Biologics S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00484276
Brief Title
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma
Acronym
NGR010
Official Title
NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGC Biologics S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
Detailed Description
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using Simon's two-stage design method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
NGR-hTNF, malignant pleural mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGR-hTNF
Arm Type
Experimental
Arm Description
NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly
Intervention Type
Drug
Intervention Name(s)
NGR-hTNF
Intervention Description
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Primary Outcome Measure Information:
Title
Antitumor activity defined as progression free survival (PFS)
Description
Defined as the time from the date of randomization until disease progression, or death
Time Frame
during the study
Secondary Outcome Measure Information:
Title
Tumor Growth Control Rate (TGCR)
Description
Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma
Time Frame
Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD
Title
Overall survival (OS)
Description
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
Time Frame
from the randomization until to the date of patient death or discontinuation from the study
Title
Experimental Imaging Study (DCE-MRI)
Description
To document possible modifications on vessels permeability by imaging techniques
Time Frame
During the treatment
Title
Cmax of NGR-hTNF in patients treated with weekly schedule
Description
to evaluate Cmax of NGR-hTNF administered weekly
Time Frame
During the treatment
Title
AUC(tau) of NGR-hTNF in patients treated with weekly schedule
Description
to evaluate AUC(tau) of NGR-hTNF administered weekly
Time Frame
During the treatment
Title
Safety according to NCI-CTCAE criteria (version 3)
Description
To evaluate safety profile related to NGR-hTNF
Time Frame
During the treatment and during the follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy ECOG Performance status 0 - 2 Adequate baseline bone marrow, hepatic and renal function, defined as follows: Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L Bilirubin < 1.5 x ULN AST and/or ALT < 2.5 x ULN in absence of liver metastasis AST and/or ALT < 5 x ULN in presence of liver metastasis Serum creatinine < 1.5 x ULN Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution) Patients may have had prior therapy providing the following conditions are met: Chemotherapy and radiotherapy: wash-out period of 28 days Surgery: wash-out period of 14 days Normal cardiac function and absence of uncontrolled hypertension Patients must give written informed consent to participate in the study Exclusion Criteria: Concurrent anticancer therapy Patients may not receive any other investigational agents while on study Clinical signs of CNS involvement 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 prior to registration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Lambiase, MD
Organizational Affiliation
AGC Biologics S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor
City
Milan
Country
Italy
Facility Name
Istituto Europeo Oncologico
City
Milan
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milan
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20406925
Citation
Gregorc V, Zucali PA, Santoro A, Ceresoli GL, Citterio G, De Pas TM, Zilembo N, De Vincenzo F, Simonelli M, Rossoni G, Spreafico A, Grazia Vigano M, Fontana F, De Braud FG, Bajetta E, Caligaris-Cappio F, Bruzzi P, Lambiase A, Bordignon C. Phase II study of asparagine-glycine-arginine-human tumor necrosis factor alpha, a selective vascular targeting agent, in previously treated patients with malignant pleural mesothelioma. J Clin Oncol. 2010 May 20;28(15):2604-11. doi: 10.1200/JCO.2009.27.3649. Epub 2010 Apr 20.
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Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma

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