A Phase 2 interventional study of NGR-hTNF in Colorectal Cancer (CRC), sponsored by AGC Biologics S.p.A.. Completed at 3 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by AGC Biologics S.p.A. · Phase 2, Interventional, and Treatment
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using Simon's two-stage design method.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 46 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →AGC Biologics S.p.A. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients >18 years affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy
Serum creatinine \< 1.5 x ULN
Exclusion Criteria:
NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every 3 weeks or weekly
Drug: NGR-hTNF
iv q3W or q1W NGR-hTNF 0.8 μg/m²
Progression Free Survival (PFS)
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
Time frame: during the study
Tumor Growth Control Rate (TGCR)
TGCR evaluated according to Response evaluation criteria in solid tumors (RECIST)
Time frame: during the study
Overall survival (OS)
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Time frame: during the study
Circulating tumor cells (CTCs)
To document modification of CTCs
Time frame: before and following the treatment
Experimental imaging study (DCE-MRI)
to document possible modifications on vessels permeability
Time frame: before and following the first cycle
to evaluate AUC(tau) of NGR-hTNF in patients treated with weekly schedule
to evaluate AUC(tau) of NGR-hTNF administered weekly
Time frame: during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start)
to evaluate Cmax of NGR-hTNF in patients treated with weekly schedule
to evaluate Cmax of NGR-hTNF administered weekly
Time frame: during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start)
Safety according to NCI-CTCAE criteria (version 3)
To evaluate safety profile related to NGR-hTNF
Time frame: during and following the treatment
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AGC Biologics S.p.A.