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

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ClinicalTrials.gov Identifier: NCT00484276
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.

June 7, 2007
June 8, 2007
October 1, 2018
May 2007
March 2013   (Final data collection date for primary outcome measure)
Antitumor activity defined as progression free survival (PFS) [ Time Frame: during the study ]
Defined as the time from the date of randomization until disease progression, or death
Antitumor activity defined as progression free survival (PFS)
Complete list of historical versions of study NCT00484276 on ClinicalTrials.gov Archive Site
  • Tumor Growth Control Rate (TGCR) [ Time Frame: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD ]
    Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma
  • Overall survival (OS) [ Time Frame: from the randomization until to the date of patient death or discontinuation from the study ]
    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) [ Time Frame: During the treatment ]
    To document possible modifications on vessels permeability by imaging techniques
  • Pharmacokinetics in patients treated with weekly schedule [ Time Frame: During the treatment ]
    to evaluate Cmax of NGR-hTNF administered weekly
  • Pharmacokinetics in patients treated with weekly schedule [ Time Frame: During the treatment ]
    to evaluate AUC(tau) of NGR-hTNF administered weekly
  • Safety according to NCI-CTCAE criteria (version 3) [ Time Frame: During the treatment and during the follow-up ]
    To evaluate safety profile related to NGR-hTNF
• Tumor Growth Control Rate (TGCR) according to RECIST criteria • Overall survival (OS)
Not Provided
Not Provided
 
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma
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

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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Pleural Mesothelioma
Drug: NGR-hTNF
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Experimental: NGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly
Intervention: Drug: NGR-hTNF
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 Viganò 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
27
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00484276
NGR010
2006-005993-39 ( EudraCT Number )
No
Not Provided
Not Provided
MolMed S.p.A.
MolMed S.p.A.
Not Provided
Study Director: Antonio Lambiase, MD MolMed S.p.A.
MolMed S.p.A.
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP