EUCTR2006-005451-15-ITActive, not recruitingNot Applicable
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
MOLMED0 sites27 target enrollmentStarted: January 24, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 27
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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