Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

Advanced Biliary Tract Adenocarcinoma Clinical Trial

Official title:

Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082809
• Other study ID #: 2009-02-025
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2010
• Last updated: May 13, 2014
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

Description:

Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18

2. histologically or cytologically confirmed adenocarcinoma of biliary tract

3. unresectable or metastatic

4. ECOG performance status of 0~2

5. measurable or evaluable lesion per RECIST criteria

6. adequate marrow, hepatic, renal and cardiac functions

7. One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)

8. provision of a signed written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections

2. pregnant or lactating women

3. active CNS metastases not controllable with radiotherapy or corticosteroids

4. known history of hypersensitivity to study drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Biliary Tract Adenocarcinoma

Intervention

Drug:
• Sunitinib
Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		12months	Yes
Secondary	Safety profile		12 months	Yes
Secondary	Response rate		12 months	Yes
Secondary	Duration of response		12 months	Yes
Secondary	Overall survival		12 months	Yes
Secondary	Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations		12 months	Yes