Z-360 in Unresectable Advanced Pancreatic Cancer in Combi... | NCT00288925

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

NCT00288925

Sponsor

Zeria Pharmaceutical

Status

Completed

Last Update Posted

Jun 1, 2009Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Pancreatic Cancer

Interventions

Z-360

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Not provided

First Submitted Date

Feb 6, 2006

First Submission Date that Met QC Criteria

Feb 6, 2006

First Posted Date

Feb 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2009

Last Update Posted Date

Jun 1, 2009Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Z-360	Drug

Measure	Description	Time Frame
Safety, Pharmacokinetics

Measure	Description	Time Frame
Tumour shrinkage, Tumour objective response rate

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Meyer, PhD, MD	Royal Free Hospital NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Free Hospital		London		NW3 2QG	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C528831	Z-360

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided