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

This study has been completed.

First Received: February 6, 2006 Last Updated: January 12, 2009 History of Changes

Sponsored by:	Zeria Pharmaceutical
Information provided by:	Zeria Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00288925

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 I Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Study ID Numbers:	01010106E
Study First Received:	February 6, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00288925 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Antiviral Agents
Immunosuppressive Agents

Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009