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

This study has been completed.
Sponsor:
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00288925
First received: February 6, 2006
Last updated: May 29, 2009
Last verified: May 2009

February 6, 2006
May 29, 2009
September 2005
December 2007   (final data collection date for primary outcome measure)
Safety, Pharmacokinetics
Same as current
Complete list of historical versions of study NCT00288925 on ClinicalTrials.gov Archive Site
Tumour shrinkage, Tumour objective response rate
Same as current
Not Provided
Not Provided
 
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pancreatic Cancer
Drug: Z-360
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
December 2007   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00288925
01010106E
Not Provided
Not Provided
Zeria Pharmaceutical
Not Provided
Principal Investigator: Tim Meyer, PhD, MD Royal Free Hospital NHS Foundation Trust
Zeria Pharmaceutical
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP