At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
S-1drug
Likely dose
S-1 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Pancreatic Cancer
In Brief
A Phase 2 clinical trial evaluating S-1 for Locally Advanced or Metastatic Pancreatic Cancer. Completed, enrolled 28 participants.
Detailed Summary
The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsQuintiles, Inc., United BioSource, LLC
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedApr 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedApr 3, 2008
Enrollment StartJan 9, 2006
Primary CompletionJul 8, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.2 years ago
Interventions
S-1drug
All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.