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Matuzumab

Phase 2

Esophageal Cancer | Small molecule | Oncology |Merck KGaA|Last Updated: Nov 2, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Matuzumab · 1 trial · 2 indications

Phase 2 1
NCT00215644Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric CancerEsophageal Cancer
COMPLETED72 Analytics
PHASE2COMPLETED
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
Esophageal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Objective Response Assessed by Independent Review Committee
Baseline up to PD or death due to any cause (up to approximately 3 years)

Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (\>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.

Secondary Endpoints

Duration of Objective Response Assessed by Independent Review Committee
From first documented objective response to PD or death due to any cause (up to approximately 3 years)
Progression-Free Survival
Baseline up to PD or death due to any cause (up to approximately 3 years)
Overall Survival (OS)
Baseline until death due to any cause (up to approximately 3 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Epirubicin, Cisplatin, Capecitabine (ECX)+MatuzumabEXPERIMENTAL -
ECX OnlyACTIVE_COMPARATOR -

Interventions

NameTypeDescription
MatuzumabDRUGParticipants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
EpirubicinDRUGParticipants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.
CisplatinDRUGParticipants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
CapecitabineDRUGParticipants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus * Metastatic disease * Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues * Eastern Cooperative Oncology Group Performance...

Countries:GermanySpainSwitzerlandUnited Kingdom
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Competitive Landscape -Esophageal Cancer 107 trials

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Frequently asked questions about Matuzumab

What is Matuzumab used for?

Matuzumab is an investigational drug being studied for the treatment of esophageal cancer and gastric cancer. It is currently in Phase 2 clinical development and is being evaluated in combination with chemotherapy for these indications.

Who is developing Matuzumab?

Matuzumab is being developed by Merck KGaA, a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with esophageal and gastric cancer.

What phase is Matuzumab in?

Matuzumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its effects in combination with chemotherapy for esophago-gastric cancer.

What clinical trials is Matuzumab in?

Matuzumab has been studied in a completed Phase 2 clinical trial with the identifier NCT00215644. This trial evaluated matuzumab in combination with epirubicin, cisplatin, and capecitabine in patients with esophago-gastric cancer, enrolling 72 participants across Germany, Spain, Switzerland, and the United Kingdom.

Is Matuzumab a small molecule drug?

Yes, Matuzumab is a small molecule drug. It is being investigated as a therapeutic option for esophageal and gastric cancer, and its clinical development is focused on oncology applications.