EXIBIT: Oxaliplatin in Biliary Tract Cancer

Phase 2

Completed

• Conditions: Biliary Tract Neoplasms

• Registration Number: NCT00174564
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.

Secondary objectives are : Progression free survival, overall survival and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate response rate according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
To evaluate the progression-free survival in the ITT population
To investigate safety using NCI-CTC criteria version 2