Cabozantinib in Advanced Adrenocortical Carcinoma
- Conditions
- Adrenocortical Carcinoma
- Interventions
- Drug: Cabozantinib-s-malate
- Registration Number
- NCT03612232
- Lead Sponsor
- Wuerzburg University Hospital
- Brief Summary
Adrenocortical carcinoma is an orphan malignant disease that has a dismal prognosis in advanced stages. Mitotane is the only approved treatment but is limited by severe toxicity. Efficacy of mitotane is unsatisfactory with an objective response rate of ≈20% in monotherapy in selected patients (Megerle et al., JCEM 2018). Cytotoxic chemotherapy with etoposide, doxorubin and cisplatin (EDP) or streptozotocin (Sz) in addition to mitotane (Fassnacht et al., N Engl J Med 2012) succeeded in a progression-free survival of 5.6 months and 2.2 months, respectively in patients with advanced ACC. Objective response rates were 23 and 9%. EDP plus mitotane is therefore considered as standard treatment of ACC. Results by Phan et al. (Cancer Research 2015) demonstrated expression of c-MET and its ligand HGF in ACC and provide a rationale to therapeutically target c-MET in ACC. In a case series of 16 patients with advanced ACC refractory to mitotane (with the exception of one case) and 3 (median, range 0-8)further lines of therapy, single agent treatment with cabozantinib off label resulted in three partial responses and five additional cases of disease stabilization for four months or longer (Kroiss et al., J Clin Endocrinol Metab 2020).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cabozantinib Cabozantinib-s-malate oral cabozantinib as tablets continuously (60 mg single dose, tablets)
- Primary Outcome Measures
Name Time Method progression free survival at 4 months 4 months
- Secondary Outcome Measures
Name Time Method overall survival 12 months best percentage change in size of target lesions 12 months treatment emergent adverse events (CTC-AE 4.03) 12 months Objective Response Rates (ORR) 12 months progression-free survival 12 months quality of life by EORTC QLQ-C30 12 months Duration of response (DR) 12 months
Trial Locations
- Locations (2)
University Hospital Munich, Department of Internal Medicine IV
🇩🇪München, Germany
University Hospital Würzburg
🇩🇪Würzburg, Germany