A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma
NCT01718327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2017-01-31
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.
Conditions
- Unresectable and Advanced Cholangiocarcinoma
Interventions
- DRUG
-
Sunitinib
sunitinib dose :37.5mg/day
Sponsors & Collaborators
-
GERCOR - Multidisciplinary Oncology Cooperative Group
lead OTHER
Principal Investigators
-
Sandrine Faivre, MD/PhD · Hôpital Beaujon
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-01
- Primary Completion
- 2016-11-17
- Completion
- 2016-11-17
Countries
- France
Study Locations
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