drugset / Trial / NCT01131364
Combination Therapy of F16IL2 and Doxorubicin in Solid Tumour Patients
NaSingle-groupOpen-labelTreatment
Summary
This Phase Ib/II study is an openlabel, multicenter study for patients with solid tumors and breast cancer amenable to anthracyclin therapy. The study is divided in two parts: Phase I: an open-label, dose escalation study of F16IL2 in combination with doxorubicin for patients with solid tumors. Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with doxorubicin, equivalent to stage 1 of the Simon two-stage phase II design, for patients with breast cancer amenable to anthracyclin therapy.
Timeline
- Start
- 2008-06
- Primary completion
- 2012-03
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | F16IL2 | Protein / enzyme biologic | 5 iu | Intravenous |
| Subject | F16IL2 | Protein / enzyme biologic | 25 iu | Intravenous |