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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288925
First Posted: February 8, 2006
Last Update Posted: June 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zeria Pharmaceutical
February 6, 2006
February 8, 2006
June 1, 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
Intervention Model: Parallel Assignment
Masking: Double
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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00288925
01010106E
Not Provided
Not Provided
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