Although a first randomized trial in patients with advanced ACC leading to the establishment
of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this
FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating
patients urgently need a new treatment option. However, up to date there is no evidence for a
single regimen that might be promising in these treatment-refractory patients with ACC.
Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and
antiangiogenic activities, which is successfully tested in the treatment of patients with
metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after
failure of standard cytotoxic chemotherapy.
The primary objective of this trial is to estimate the response (defined as progression-free
survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC
progressing after cytotoxic chemotherapy.