Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-07-15
First Post:
2018-07-12
Brief Title:
Cabozantinib in Advanced Adrenocortical Carcinoma
Sponsor:
Wuerzburg University Hospital
Organization:
Wuerzburg University Hospital
Study Overview
Official Title:
A Multicenter Open-label Phase II Study to Evaluate the Efficacy and Safety of Cabozantinib in Advanced Unresectable or Metastatic Adrenocortical Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaboACC
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 56 months and 22 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 0-8further 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None