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Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors

Cancer Clinical Trial

Official title:
A Phase IB Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Solid Tumors

Clinical Trial Summary

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 doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

Clinical Trial Description

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 previously treated with a non cumulative dose of doxorubicin (<300 mg/sqm in order to allow an adequate number of cycles) or chemotherapy naïve will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00305084
Study type Interventional
Source MolMed S.p.A.
Contact
Status Completed
Phase Phase 1
Start date February 28, 2006
Completion date May 8, 2007
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