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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• Antitumor activity defined as progression free survival (PFS)

Outcome Time Frame:

during the study

Safety Issue:

No

Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.

Authority:

Italy: Ethics Committee

Study ID:

NGR010

NCT ID:

NCT00484276

Start Date:

May 2007

Completion Date:

June 2013

Related Keywords:

  • Malignant Pleural Mesothelioma
  • NGR-hTNF
  • malignant pleural mesothelioma
  • Mesothelioma

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