drugset / Trial / NCT01490047
Single Dose of Intravenous rhTNF-α and Liposomal Doxorubicin in Patients With Advanced Solid Tumors or Lymphomas
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of recombinant human tumor necrosis factor-α (rhTNF-α) when given as a single dose intravenously and in combination with liposomal doxorubicin in human subjects
Timeline
- Start
- 2013-01
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | — |
| Subject | Recombinant human TNF-α | Protein / enzyme biologic | 25 ug/m2 | Intravenous |
| Subject | Recombinant human TNF-α | Protein / enzyme biologic | 50 ug/m2 | Intravenous |
| Subject | Recombinant human TNF-α | Protein / enzyme biologic | 100 ug/m2 | Intravenous |
| Subject | Recombinant human TNF-α | Protein / enzyme biologic | 150 ug/m2 | Intravenous |
| Subject | Recombinant human TNF-α | Protein / enzyme biologic | 200 ug/m2 | Intravenous |
| Subject | Recombinant human TNF-α | Protein / enzyme biologic | 250 ug/m2 | Intravenous |