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DOS

Phase 2

Stomach Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Sep 21, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

DOS · 1 trial · 1 indication

Phase 2 1
NCT00525005Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric CancerStomach Neoplasms
COMPLETED44 Analytics
PHASE2COMPLETED
Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer
Stomach NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

overall response rate
2.5 years

Secondary Endpoints

safety, progression-free survival, and overall survival
2.5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DOS (Docetaxel, Oxaliplatin and S-1)EXPERIMENTALDocetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)

Interventions

NameTypeDescription
DOS (Docetaxel, Oxaliplatin and S-1)DRUGDocetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma, initially diagnosed or recurred * Unresectable, locally advanced or metastatic * At least one uni-dimensional measurable lesion by RECIST criteria * Age 18 to 70 years old * ECOG performance status ≤2 * Estimated life expectancy...

Countries:South Korea
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