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S-1

Phase 1

Stomach Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Mar 13, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

S-1 · 1 trial · 1 indication

Phase 1 1
NCT00553696Study Of Sunitinib With S-1 And Cisplatin For Gastric CancerStomach Neoplasms
COMPLETED27 Analytics
PHASE1COMPLETED
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Stomach NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
Cycle 1 (Baseline to Week 4)

A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
CisplatinDRUGCisplatin 60 mg/m2 on day 1 of each 28 day cycle
S-1DRUGS-1 80 mg/m2 on days 1-21 of each 28 day cycle
SunitinibDRUGSunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of gastric cancer * Chemonaive patients * Adequate organ function Exclusion Criteria: * Patients who meet the contra-indications of S-1 and Cisplatin. * Prior chemotherapy failure patients

Countries:Japan
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Frequently asked questions about S-1

What is S-1 used for?

S-1 is an investigational small molecule being studied for the treatment of stomach neoplasms, which are tumors of the stomach. It is in Phase 1 clinical development for this oncology indication.

Who is developing S-1?

S-1 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is S-1 in?

S-1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of stomach neoplasms.

What clinical trials is S-1 in?

S-1 has been studied in a completed Phase 1 clinical trial with the identifier NCT00553696. This trial, titled "Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer," enrolled 27 participants in Japan and was an uncontrolled, non-randomized study.

What is the mechanism of action of S-1?

S-1 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in the available information, so its precise mechanism of action is not detailed here.