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NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose

This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced
solid tumors for the definition of an optimal biological

Inclusion Criteria:

- Patients >18 years old with proven advanced solid tumors not amenable to any clinical
improvement by current standard treatments. Tumors recognized to be highly
vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included.

- ECOG Performance status 0 - 2

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

- Chemo, radio, hormonal or immunotherapy: wash-out period of 28 days

- Surgery: wash-out period of 14 days

- 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 metastases

- AST and/or ALT < 5 x ULN in presence of liver metastases

- 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 (reference appendix "Technical data sheet human albumin")

- 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:


Study Design:

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

Outcome Measure:

To verify safety of escalating doses of NGR-hTNF

Outcome Time Frame:

during and following the treatment

Safety Issue:


Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.


Italy: National Institute of Health

Study ID:




Start Date:

March 2005

Completion Date:

September 2007

Related Keywords:

  • Advanced Solid Tumors
  • solid tumors NGR-hTNF
  • Neoplasms