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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
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288925


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

ClinicalTrials.gov Identifier: NCT00288925     History of Changes
Other Study ID Numbers: 01010106E
First Submitted: February 6, 2006
First Posted: February 8, 2006
Last Update Posted: June 1, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs