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NCT00288925 Clinical Trial

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

Pancreatic Cancer Clinical Trial

Official title:
Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00288925
Other study ID # 01010106E
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 6, 2006
Last updated May 29, 2009
Start date September 2005

Study information
Verified date May 2009
Source Zeria Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Z-360

Locations
Country Name City State
United Kingdom Royal Free Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety, Pharmacokinetics
Secondary Tumour shrinkage, Tumour objective response rate
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