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S-1

Phase 2

Gastric Cancer | Small molecule | Oncology |Merck KGaA|Last Updated: Nov 20, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

S-1 · 1 trial · 1 indication

Phase 2 1
NCT01388790Cetuximab in Combination With S-1 and Cisplatin in Gastric CancerGastric Cancer
COMPLETED40 Analytics
PHASE2COMPLETED
Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments
Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)

The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 \[RECIST v 1.0\] criteria).

Secondary Endpoints

Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cetuximab plus cisplatin plus S-1EXPERIMENTAL -

Interventions

NameTypeDescription
CetuximabDRUGSingle first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m\^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
CisplatinDRUGCisplatin 60 mg/m\^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent
S-1DRUGS-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written informed consent and agreement with medically accepted contraception (in participants with conception potential) are obtained * Japanese participants aged greater than or equal to 20 years * Histologically confirmed adenocarcinoma of the stomach or GEJ (adenocarcinomas...

Countries:Germany
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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 other agents as a potential therapy for this indication. The drug is currently in clinical development and has not been approved for use.

Who makes S-1?

S-1 is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is an investigational small molecule in Phase 2 clinical development for gastric cancer.

What phase is S-1 in?

S-1 is in Phase 2 clinical development. It has completed one Phase 2 trial for gastric cancer, and the drug remains investigational, meaning it has not yet 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 NCT01388790. This trial, titled "Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer," enrolled 40 participants in Germany and evaluated the drug in patients with gastric cancer.

Is S-1 the same as other drugs?

S-1 is the drug name used in clinical development by Merck KGaA. No alternative names have been reported for this investigational agent in the context of its gastric cancer program.