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

This study has been completed.
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
First received: February 6, 2006
Last updated: May 29, 2009
Last verified: May 2009
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

Condition Intervention Phase
Pancreatic Cancer
Drug: Z-360
Phase 1
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • Safety, Pharmacokinetics

Secondary Outcome Measures:
  • Tumour shrinkage, Tumour objective response rate

Estimated Enrollment: 30
Study Start Date: September 2005
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00288925

United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Zeria Pharmaceutical
Principal Investigator: Tim Meyer, PhD, MD Royal Free Hospital NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00288925     History of Changes
Other Study ID Numbers: 01010106E 
Study First Received: February 6, 2006
Last Updated: May 29, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on February 11, 2016