A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma (SUN-CK)
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|ClinicalTrials.gov Identifier: NCT01718327|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : January 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Unresectable and Advanced Cholangiocarcinoma||Drug: Sunitinib||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma|
|Actual Study Start Date :||September 1, 2011|
|Primary Completion Date :||November 17, 2016|
|Study Completion Date :||November 17, 2016|
Experimental: open label, single arm
single arm: sunitinib until progresion or unacceptable toxicity
sunitinib dose :37.5mg/day
Other Name: sutent
- Overall survival [ Time Frame: time interval from first sunitinib dose to the date of death as a result of any cause assessed up to 3 years ]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.
- To evaluate the criteria of efficacy (PFS, ORR) [ Time Frame: time interval from first sunitinib dose to documented disease progression or death due to any cause, assessed up to 3 years after the beginning of the study ]
Criteria of efficacy will be determined by:
- The time to progression under treatment defined as time from first sunitinib dose to documented disease progression or death due to any cause.
- The objective response rate (ORR) defined as the percentage of all patients who experienced a confirmed complete response (CR) and partial response (PR) based on RECIST criteria. The best overall response, defined as the best response recorded from the start of the treatment until disease progression/recurrence, will be considered.
- To evaluate the effects of sunitinib on tumor angiogenesis [ Time Frame: Time interval from baseline to the end of treatment, an expected average of 6 months ]
The effects of sunitinib on tumor angiogenesis will be determined using the following imaging techniques:
- Tumor density modification assessed on CT-scan
- The functional response according to modifications of vascular permeability assessed by either dynamic contrast-enhanced (DCE) magnetic resonance imaging parameters and/or diffusion MRI.
- To characterize the safety profile of sunitinib (collection of AEs) [ Time Frame: Time interval from study entry to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study, assessed up to 7 months after the beginning of the study ]
Safety will be determined in this patient population by the evaluation of adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events.
In order to ensure complete safety data collection, all AEs occurring during the study, including any pre- and post-treatment periods required by the protocol must be recorded.
The period of observation for this study is from signature of informed consent or visit 1 to 1 month after last study drug administration.
Post-treatment follow up (including assessment/follow-up of adverse events) will be performed every 2 months
- To identify markers associated with response to sunitinib [ Time Frame: Time interval from baseline to the end of treatment, an expected average of 6 months ]markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718327
|Clichy, France, 92118|
|Hôpital privé Jean Mermoz|
|Lyon, France, 69008|
|CHU La Timone|
|Marseille, France, 13005|
|Hôpital Saint Antoine|
|Paris, France, 75012|
|Institut Mutualiste Montsouris|
|Paris, France, 75014|
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|Principal Investigator:||Sandrine Faivre, MD/PhD||Hôpital Beaujon|