Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-15 @ 12:24 AM
Study NCT ID:
NCT01718327
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2012-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
Study Overview
Official Title:
A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma
Status:
COMPLETED
Status Verified Date:
2017-01
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:
SUN-CK
Brief Summary:
For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered as the reference treatment in first line chemotherapy. However, the outcomes of these patients remain limited and therefore more effective drugs are warranted. The context of the disease and current data on sunitinib suggest that sunitinib may have activity in patients with advanced non resectable cholangiocarcinoma.
Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity of sunitinib in such a patient population.
Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity of sunitinib in such a patient population.
Detailed Description:
The primary objective is to evaluate the overall survival of patients with advanced and unresectable cholangiocarcinoma treated continuously by sunitinib as second line at the dose of 37.5 mg per day, after one line of chemotherapy and to determine whether sunitinib deserves further studies in this indication.
The secondary objectives are
* To evaluate the criteria of efficacy
* To evaluate the effects of sunitinib on tumor angiogenesis
* To characterize the safety profile of sunitinib
* To identify markers associated with response to sunitinib
The secondary objectives are
* To evaluate the criteria of efficacy
* To evaluate the effects of sunitinib on tumor angiogenesis
* To characterize the safety profile of sunitinib
* To identify markers associated with response to sunitinib
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-000073-30 | EUDRACT_NUMBER | None | View |