Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor
The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor|
- To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks [ Time Frame: To recommend a dose regimen of NGR-hTNF + Cisplatin for future phase II trials ] [ Designated as safety issue: Yes ]
- To document the preliminary antitumor activity of the combination in terms of objective response rate according to RECIST criteria [ Time Frame: every six weeks ] [ Designated as safety issue: No ]
- To evaluate the pharmacokinetic profiles of the combination of NGR-hTNF and cisplatin [ Time Frame: During the study ] [ Designated as safety issue: No ]
- To measure plasma levels of sTNFRs and anti-NGR-hTNF antibodies [ Time Frame: During the study ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqmDrug: Cisplatin
iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles
This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.
Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.
|Fondazione San Raffaele del Monte Tabor|
|Milan, Milan,, Italy|
|Istituto Europeo Oncologico|
|Study Director:||Antonio Lambaise, MD||MolMed S.p.A.|