A SINGLE CENTRE, OPEN LABEL, PHASE II CLINICAL STUDY OF THE ADJUNCTIVE BENEFIT OF WF10 TO STANDARD CAPECITABINE CHEMOTHERAPY IN SUBJECTS WITH UNRESECTABLE PANCREATIC CANCER

Registry ID
EUCTR2005-003553-27
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
DIMETHAID AG
Start date
2005-11-28
Completion date
2008-12-15
Last update
2026-08-16

Conditions

Summary

The objective of this study is to investigate the safety and efficacy of adjunctive therapy with WF10 when combined with capecitabine therapy in subjects with unresectable cancer of the pancreas. Efficacy will be measured by both objective measures, including growth of the tumor and subject survival, and subjective subject parameters of pain and overall well-being. Primary Efficacy Endpoint: Survival. Secondary Efficacy Endpoints :Tumor Response, Duration of Overall Tumor Response, Duration of Stable Disease (Time to Disease Progression). Other survival parameters to be evaluated include: 12-month survival and median overall survival, Tumor Marker CA19-9, Quality of Life, Pain Assessment and Immunological Assessment.

Locations

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