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

Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00288925
Enrollment
30
Registered
2006-02-08
Start date
2005-09-30
Completion date
Unknown
Last updated
2009-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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

Interventions

DRUGZ-360

Sponsors

Zeria Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety, Pharmacokinetics

Secondary

MeasureTime frame
Tumour shrinkage, Tumour objective response rate

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026