NCT00288925

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

June 1, 2009

Status Verified

May 1, 2009

Enrollment Period

2.2 years

First QC Date

February 6, 2006

Last Update Submit

May 29, 2009

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety, Pharmacokinetics

Secondary Outcomes (1)

  • Tumour shrinkage, Tumour objective response rate

Interventions

Z-360DRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with unresectable locally advanced or metastatic pancreatic cancer
  • KPS \> 70%
  • Life expectancy of at least 3 months

You may not qualify if:

  • received previous chemotherapy for the current indication
  • received previous radiotherapy for the current indication
  • Currently receiving chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Z-360

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Tim Meyer, PhD, MD

    Royal Free Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Last Updated

June 1, 2009

Record last verified: 2009-05

Locations

GB(1)