Status:
COMPLETED
Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metastatic solid ...
Detailed Description
Pre-clinical studies provide the support that NGR-TNF is endowed with a higher therapeutic index in animal models and studies of the mechanism of action showed that NGR-TNF can induce tumour necrosis ...
Eligibility Criteria
Inclusion
- Patients ≥18 years with selected metastatic solid tumours recognized to be highly vascularised and not amenable to any clinical improvement by current standard treatments
- Colorectal cancer (CRC) patients previously resistant to standard systemic regimens (including biologic agents)
- Gastric cancer (GC) patients treated with no more than two standard systemic regimens for metastatic disease
- Hepatocellular carcinoma (HCC) patients previously resistant to standard systemic regimens
- Pancreatic carcinoma (PC) patients treated with no more than one standard systemic regimen for metastatic disease
- Non small cell lung carcinoma (NSCLC) patients treated with no more than two standard systemic regimens (including biologic agents) for metastatic disease
- Neuroendocrine (NE) tumours refractory to somatostatin analogue treatment
- Other rare tumours including malignant pleural mesothelioma (MPM), soft-tissue sarcoma (STS), and renal cell carcinoma (RCC), resistant/refractory to current standard treatments
- Life expectancy more than 3 months
- ECOG Performance status 0-1
- 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 ml/min
- Patients may have had prior therapy providing the following conditions are met before treatment start:
- Chemotherapy, radiation therapy, hormonal therapy, or immunotherapy: wash-out period of 28 days
- Surgery: wash-out period of 14 days
- Patients must give written informed consent to participate in the study.
Exclusion
- Concurrent anticancer therapy
- Patients must not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension
- Prolonged QTc interval (congenital or acquired) \> 450 ms
- Patient with significant peripheral vascular disease
- History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy), or history of stroke
- 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 or contraindications 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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00878111
Start Date
April 1 2009
End Date
February 1 2017
Last Update
August 29 2018
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089