NCT01718327

A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma

A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Unresectable and Advanced Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Sunitinib	sunitinib dose :37.5mg/day

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-11-17
• Completion: 2016-11-17
• First posted: 2012-10-31
• Last updated: 2017-01-31

Locations

6 sites across 1 country: France