Conditions: Adrenocortical Carcinoma
Keywords: Adrenal cancer refractory to cytotoxic therapy Sunitinib Multitargeted tyrosine-kinase inhibitor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.

treatment will continue until progressive disease or unacceptable toxicity

Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: 50mg Sunitinib

Protocol document: