Patients affected by advanced or metastatic colorectal cancer CRC. Level: PT Classification code 10061451
Conditions
Interventions
Product Name: NGR-hTNF
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OTHER ANTINEOPLASTIC AGENTS
Current Sponsor code: NGR-hTNF
Other descriptive name: ARENEGYR
Conce
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years affected by advanced or metastatic colorectal cancer CRC , previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens. Adjuvant chemotherapy following definitive management of the primary lesion is allowed and will not be counted as a line of therapy ECOG Performance status 0 1 Patients in progression disease at study entry CT documented Adequate baseline bone marrow, hepatic cardiac and renal functions -absence of any conditions in which hypervoleamia and its consequences Patients must give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: More than three lines of chemotherapy except biological agents 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antitumour activity defined as Progression Free Survival.;Secondary Objective: Tumor Growth Control Rate TGCR Overall survival OS Evaluation of Circulating Tumor Cells CTC and Circulating Endothelial Cells CEC Experimental Imaging Study DCE-MRI Evaluation of adaptative immune response Safety.;Primary end point(s): Antitumour activity defined as Progression Free Survival | — |
Countries
Italy
Outcome results
None listed