Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

Phase 1

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00288925
• Lead Sponsor: Zeria Pharmaceutical

Brief Summary

To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-08
• Primary Completion: 2007-12
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-29
• Last Update Posted: 2009-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects with unresectable locally advanced or metastatic pancreatic cancer
• KPS > 70%
• Life expectancy of at least 3 months

Exclusion Criteria

• received previous chemotherapy for the current indication
• received previous radiotherapy for the current indication
• Currently receiving chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety, Pharmacokinetics

Secondary Outcome Measures

Name	Time	Method
Tumour shrinkage, Tumour objective response rate

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom