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Epirubicin

Phase 2

Gastric Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 29, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

Epirubicin · 1 trial · 1 indication

Phase 2 1
NCT00454636A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.Gastric Cancer
COMPLETED158 Analytics
PHASE2COMPLETED
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
Approximately 3.25 years

Secondary Endpoints

Overall Response Rate (ORR)
Approximately 3.25 years
Progression-Free Survival (PFS)
Approximately 3.25 years
Overall Survival (OS)
Approximately 3.25 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cisplatin / CapecitabineEXPERIMENTALCisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Epirubicin / Cisplatin / CapecitabineEXPERIMENTALEpirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
Epirubicin / Oxaliplatin / CapecitabineEXPERIMENTALEpirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
Docetaxel / Cisplatin / CapecitabineEXPERIMENTALDocetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.

Interventions

NameTypeDescription
CisplatinDRUG80 mg/m2/day, intravenous (IV), every 3 weeks
CapecitabineDRUG1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
EpirubicinDRUG50 mg/m2/day, IV, every 3 weeks
OxaliplatinDRUG130 mg/m2/day, IV, every 3 weeks
DocetaxelDRUG60 mg/m2/day, IV, every 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * adult patients, \>=18 years of age; * advanced or metastatic gastric cancer; * Eastern Cooperative Oncology Group (ECOG) \<=2. Exclusion Criteria: * previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to study); * evidence of central nervous sys...

Countries:Spain
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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 Epirubicin

What is Epirubicin used for in gastric cancer?

Epirubicin is an oncology small molecule being studied for use in gastric cancer. In clinical development, it is being evaluated in combination with other chemotherapy agents for patients with advanced and/or metastatic gastric cancer. The drug is currently in Phase 2 clinical trials for this indication.

What does Epirubicin target?

Epirubicin is a small molecule oncology drug. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being studied in combination with capecitabine and other chemotherapy for the treatment of advanced and/or metastatic gastric cancer.

Who makes Epirubicin?

Epirubicin is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on the drug for the treatment of gastric cancer.

What phase is Epirubicin in?

Epirubicin is in Phase 2 clinical development for gastric cancer. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is Epirubicin in?

Epirubicin has been studied in one completed Phase 2 clinical trial, NCT00454636. This trial evaluated capecitabine in combination with chemotherapy, including epirubicin, in 158 patients with advanced and/or metastatic gastric cancer. The study was conducted in Spain and enrolled adults aged 18 years and older.

Is Epirubicin the same as other drugs?

Epirubicin is not known to have alternative names in the available clinical trial information. It is being studied as a distinct chemotherapy agent in combination regimens for gastric cancer.