drugset / Trial / NCT00305084
Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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 ).
Timeline
- Start
- 2006-02-28
- Primary completion
- 2007-05-08
- Completion
- 2007-05-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NGR-hTNF | Protein / enzyme biologic | 0.2 ug/m2 | Intravenous |
| Subject | NGR-hTNF | Protein / enzyme biologic | 0.4 ug/m2 | Intravenous |
| Subject | NGR-hTNF | Protein / enzyme biologic | 0.8 ug/m2 | Intravenous |
| Subject | NGR-hTNF | Protein / enzyme biologic | 1.6 ug/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |