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Epirubicin, Cisplatin, Capecitabine, Panitumumab

Phase 2

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

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment171

FDA Designations

No designations recorded

Clinical trial landscape

Epirubicin, Cisplatin, Capecitabine, Panitumumab · 1 trial · 2 indications

Phase 2 1
NCT01234324ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal JunctionStomach Neoplasms
COMPLETED171 Analytics
PHASE2COMPLETED
ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction
Stomach NeoplasmsUnlock trial analytics

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 to 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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Frequently asked questions about Epirubicin, Cisplatin, Capecitabine, Panitumumab

What is Epirubicin used for?

Epirubicin is an oncology small molecule being studied for stomach neoplasms, breast cancer, and esophagogastric junction adenocarcinoma. It is currently in Phase 3 clinical development. Epirubicin is being evaluated in combination with other agents in clinical trials for these cancer types.

Who makes Epirubicin?

Epirubicin is being developed by Amgen Inc., which trades under the ticker AMGN. The company is conducting clinical trials to evaluate the drug in oncology indications including breast cancer and gastric cancers.

What phase is Epirubicin in?

Epirubicin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in completed Phase 3 trials for early breast cancer and in earlier-phase trials for gastric and esophagogastric junction cancers.

What clinical trials is Epirubicin in?

Epirubicin has been studied in several completed trials. NCT00309556 was a Phase 3 randomized neoadjuvant study in early breast cancer. NCT00719550 was a Phase 1 trial combining epirubicin with AMG 102 for gastric or esophagogastric junction cancer. NCT01234324 was a Phase 2 trial of epirubicin with panitumumab in gastric cancer. NCT01690702 was a Phase 3 study in high-risk early breast cancer.

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 other therapies for the treatment of breast cancer and gastric cancers.

Is Epirubicin the same as AMG 102?

No, Epirubicin is not the same as AMG 102. In clinical trial NCT00719550, epirubicin was combined with AMG 102, which is a separate investigational agent. Epirubicin is the chemotherapy drug being evaluated in that trial, while AMG 102 is the experimental combination partner.