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Completed

NCT Number: NCT00288925

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

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

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Z-360

Drug

Primary outcomes

  1. Safety, Pharmacokinetics

Secondary outcomes

  1. Tumour shrinkage, Tumour objective response rate

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
First posted
Feb 8, 2006
Registry last updated
Jun 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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