ACC MedDRA version: 9.1 Level: SOC Classification code 10014698 Term: Endocrine disorders MedDRA version: 9.1 Level: LLT Classification code 10001326 Term: Adrenal carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - histologically confirmed diagnosis of ACC - locally advanced or metastatic disease not amenable to radical surgery resection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - history of prior malignancy - severe renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity and side effects of Sorafenib plus weekly Paclitaxel;Secondary Objective: To assess che clinical benefit as misured by a non progressing rate after 4 months;Primary end point(s): - survival without disease mprogression | — |
Countries
Italy