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Recently added Catalysts

Epirubicin, Cisplatin, Capecitabine, Panitumumab

Phase 2

Stomach Neoplasms | Small molecule | Oncology |Amgen Inc.|Last Updated: Jan 23, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment171
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01234324ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal JunctionPHASE2 COMPLETED 171Oct 1, 2010Aug 1, 2017Jan 23, 20181 Germany
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Study Endpoints
Primary Endpoints
Frequency of pT3/T4 categories after surgery
after 9 weeks treatment
Secondary Endpoints
Frequencies of pN2/N3 categories after surgery
After 9 weeks treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: ECX + PanitumumabEXPERIMENTAL -
Arm 2: EXC aloneACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Epirubicin, Cisplatin, Capecitabine, PanitumumabDRUGEpirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle; Panitumumab: 9 mg/kg bodyweight, administered IV by an infusion pump through a peripheral line or catheter over 60 min +-15 min on day 1 of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.
Epirubicin, Cisplatin, CapecitabineDRUGEpirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Competent to comprehend, sign, and date an IEC-approved informed consent form, written informed consent. * Of either gender and aged 18 years or more. * Diagnosed with histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction of Type I/II/III acco...

Countries:Germany
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