Back to resultsZ-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Z-360
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility 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
Sites / Locations
- Royal Free Hospital
Outcomes
Primary Outcome Measures
Safety, Pharmacokinetics
Secondary Outcome Measures
Tumour shrinkage, Tumour objective response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00288925
Brief Title
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Z-360
Primary Outcome Measure Information:
Title
Safety, Pharmacokinetics
Secondary Outcome Measure Information:
Title
Tumour shrinkage, Tumour objective response rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Meyer, PhD, MD
Organizational Affiliation
Royal Free Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
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