Patients with metastatic colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastatic
Conditions
Interventions
Product Name: NGR-hTNF
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: NGR-hTNF
Other descriptive name: ARENEGYR
Concentration unit: µg/ml microgram(s)/millilitre
Conc
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients ≥18 years with metastatic colorectal cancer (CRC) treated with no more than three standard systemic regimens (including biologic agents) for metastatic disease 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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) 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 Symptomatic peripheral neuropathy grade 1 according the NCI CTCAE v.3.0. Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients Known hypersensitivity/allergic reaction or contraindications to platinum compounds or fluoropyrimidines 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility and safety of NGR-hTNF administered at low (0.8 μg/m2) and high (45 μg/m2) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer.;Secondary Objective: To document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival To evaluate the pharmacokinetic profile of NGR-hTNF and to measure plasma levels of sTNF-RI and sTNF-RII;Primary end point(s): To determine the feasibility and safety of NGR-hTNF administered at low (0.8 μg/m2) and high (45 μg/m2) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer. | — |
Countries
Italy
Outcome results
None listed