The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments
Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
iv 0.8 or 45 mcg/sqm q3W
iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion
orally 825 mg/sqm 2qDx14
Azienda Ospedaliera Universitaria San Martino
Genoa, Genoa, Italy
To determine the feasibility and safety of NGRhTNF administered at low (0.8 mcg/sqm) and high (45 mcg/sqm) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer.
Time frame: during the study
Document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival
Time frame: during the study
Evaluate the pharmacokinetic profile of NGRhTNF and to measure plasma levels of sTNF-RI and sTNF-RII
Time frame: before during and following the treatment
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