Sunitinib as Second-line Treatment in Advanced Biliary Tr... | NCT01082809

Studies
Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

NCT01082809

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

May 14, 2014Estimated

Enrollment

59Actual

Phase

Phase 2

Conditions

Advanced Biliary Tract Adenocarcinoma

Interventions

Sunitinib

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jan 7, 2010

First Submission Date that Met QC Criteria

Mar 8, 2010

First Posted Date

Mar 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2014

Last Update Posted Date

May 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sunitinib	No Intervention	Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle	Drug: Sunitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunitinib	Drug	Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle	Sunitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression		12months

Secondary Outcomes

Measure	Description	Time Frame
Safety profile		12 months
Response rate		12 months
Duration of response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥ 18
histologically or cytologically confirmed adenocarcinoma of biliary tract
unresectable or metastatic
ECOG performance status of 0~2
measurable or evaluable lesion per RECIST criteria
adequate marrow, hepatic, renal and cardiac functions
One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
provision of a signed written informed consent

Exclusion Criteria:

severe co-morbid illness and/or active infections
pregnant or lactating women
active CNS metastases not controllable with radiotherapy or corticosteroids
known history of hypersensitivity to study drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ho yeong Lim, M.D,Ph.D	Samsung Medical Center, Seoul, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22176869	Derived	Yi JH, Thongprasert S, Lee J, Doval DC, Park SH, Park JO, Park YS, Kang WK, Lim HY. A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: a multicentre, multinational study. Eur J Cancer. 2012 Jan;48(2):196-201. doi: 10.1016/j.ejca.2011.11.017. Epub 2011 Dec 14.

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds