Combination Therapy of F16IL2 and Doxorubicin in Solid Tumour Patients
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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.