Clinical trialPhase 1 / Phase 2Completed
The Study of Metastatic Pancreatic Adenocarcinoma
Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- March 2012
- Expected end
- April 2016
- Enrollment
- 73 participants
- Sites
- 1
- Primary outcomes
- to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG
- Sponsor
- Other
- Results posted
- No
- Last update
- 4 May 2016
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Brief summary public domain (ClinicalTrials.gov)
Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study
Detailed description public domain (ClinicalTrials.gov)
Phase I: 2\~24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's design of 25 patients in the first stage and 27 patients in the second stage.