GR006 A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by colorectal cancer CRC , previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens. - NGR006
- Conditions
- Patients affected by advanced or metastatic colorectal cancer CRC.Level: PTClassification code 10061451
- Registration Number
- EUCTR2006-005451-15-IT
- Lead Sponsor
- MOLMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 27
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method