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S-1

Phase 2

Gastric Cancer | Small molecule | Oncology |Sanofi|Last Updated: Dec 18, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

S-1 · 1 trial · 1 indication

Phase 2 1
NCT00816543Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal AdenocarcinomaGastric Cancer
COMPLETED41 Analytics
PHASE2COMPLETED
Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

R0 resection rate
At the end of the treatment period

Secondary Endpoints

Physical examination
Every 3 months during the study period
Chest X-Ray
Throughout the study period
Computed Tomography scan of the abdomen
Every 6 months during the study period
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.

Interventions

NameTypeDescription
DOCETAXELDRUG50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
S-1DRUG80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.
OXALIPLATINDRUG100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-esophageal adenocarcinoma, that is considered operable. * The bulk of disease must be localized in the stomach, although the gastroesophageal junction may be involved. * Patients with T3 ...

Countries:South Korea
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Competitive Landscape -Gastric Cancer 112 trials

Top 20 of 45 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab, paclitaxel, Paclitaxel, Docetaxel
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY6PHASE2Pumitamig, Folfox, Capox, Nivolumab
Pfizer Inc.PFE7PHASE2disitamab vedotin, tucatinib
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography/Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106- Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed/m2, Cisplatin/m2
Incyte CorporationINCY1PHASE2Capecitabine, Oxaliplatin, Retifanlimab
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
Enliven Therapeutics, Inc.ELVN1PHASE1ELVN-002, Trastuzumab, 5-Fluorouracil, Oxaliplatin, Capecitabine
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Frequently asked questions about S-1

What is S-1 used for in gastric cancer?

S-1 is an investigational small molecule being studied for the treatment of gastric cancer. It is being evaluated in combination with docetaxel and oxaliplatin in patients with potentially operable gastric or gastroesophageal adenocarcinoma. The drug is still in clinical development and is not approved.

Who is developing S-1?

S-1 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical development for gastric cancer.

What phase is S-1 in?

S-1 is in Phase 2 clinical development for gastric cancer. It has completed one Phase 2 trial, and the drug remains investigational. It has not been approved by regulatory authorities.

What clinical trials is S-1 in?

S-1 has been studied in a completed Phase 2 clinical trial with the identifier NCT00816543. The trial evaluated docetaxel plus oxaliplatin plus S-1 in patients with potentially operable gastric or gastroesophageal adenocarcinoma. The study enrolled 41 participants in South Korea.

Is S-1 the same as other drugs?

S-1 is the drug name used in clinical development. No alternative names have been established for this drug in the available information. It is being studied under the name S-1 in the context of gastric cancer treatment.