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NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted
in sequential cohorts of patients. Three patients per each cohort are planned.

Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be

Inclusion Criteria:

- Patients ≥18 years with advanced or metastatic solid tumor not amenable to any
clinical improvement by current standard treatments and suitable for a treatment with

- Life expectancy more than 3 months

- ECOG Performance status 0-1

- Absence of any conditions in which hypervolemia and its consequences (e.g.
increased stroke volume, elevated blood pressure) may represent a risk for the

- 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

- Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50

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

- Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period
of 28 days

- Corticosteroid therapy wash out period of 14 days

- Surgery: wash-out period of 14 days

- Patients must give written informed consent to participate in the study

Exclusion Criteria:

- Previous signs of severe toxicity platinum related

- Patients must not receive any other investigational agents while on study

- New York Heart Association class III or IV cardiac disease

- Unstable angina

- Patients with myocardial infarction within the last six (6) months

- Patient with significant peripheral vascular disease

- 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 Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks

Outcome Time Frame:

To recommend a dose regimen of NGR-hTNF + Cisplatin for future phase II trials

Safety Issue:


Principal Investigator

Antonio Lambaise, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.


Italy: National Institute of Health

Study ID:




Start Date:

July 2007

Completion Date:

June 2013

Related Keywords:

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