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Clinical Trials/EUCTR2006-002727-16-DE
EUCTR2006-002727-16-DE
Active, not recruiting
Not Applicable

Multicenter, open-label phase II study to evaluate the safety and efficacy of the tri-functional bispecific antibody catumaxomab (anti-EpCAM x anti-CD3) in patients with gastric adenocarcinoma after neoadjuvant chemotherapy and intended curative resection - n.a.

Fresenius Biotech GmbH0 sites70 target enrollmentNovember 1, 2006
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ConditionsGastric Neoplasm malignantMedDRA version: 15.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Cancer [C04]
DrugsRemovab

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Neoplasm malignant
Sponsor
Fresenius Biotech GmbH
Enrollment
70
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 1, 2006
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fresenius Biotech GmbH

Eligibility Criteria

Inclusion Criteria

  • •1\. Signed and dated informed consent
  • •2\. Male or female patient at an age of 18 years or older
  • •3\. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert\-Type 2 or 3\)
  • •4\. TNM\-staging at screening of T2/T3/T4, N\+/\-, M0
  • •5\. Intended curative subtotal or total gastrectomy ('en\-bloc'\-R0\-resection considering the standard D2\-scheme)
  • •6\. Karnofsky index \>\= 70
  • •7\. Negative pregnancy blood test at screening but not more than 72 hours prior to the start of chemotherapy, for women of childbearing potential
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. Exposure to prior cancer therapy (surgery, chemo\- or radio\-therapy) or planned adjuvant chemo\- or radiotherapy of the current gastric cancer before End\-of\-Treatment visit (EOT \= 1 month after last catumaxomab administration)
  • •2\. Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except cervix carcinoma in situ and adequately treated non\-melanomatous skin cancer)
  • •3\. Previous use of non\-humanized monoclonal mouse or rat antibodies
  • •4\. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies or to any of the planned ECX chemotherapeutic drugs
  • •5\. Known dihydropyrimidine\-dehydrogenase (DPDH) deficiency
  • •6\. Known contraindications to any of the planned ECX\-chemotherapeutics
  • •7\. Presence of distant metastases
  • •8\. Presence of constant immunosuppressive therapy
  • •9\. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension
  • •10\. Presence of symptomatic pyloric stenosis (defined as excessive vomiting and weight loss \> 10% within the last 3 months)

Outcomes

Primary Outcomes

Not specified

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Multicenter, open-label phase II study to evaluate the safety and efficacy of the tri-functional bispecific antibody catumaxomab (anti-EpCAM x anti-CD3) in patients with gastric adenocarcinoma after neoadjuvant chemotherapy and intended curative resection - n.a.Gastric Neoplasm malignantMedDRA version: 8.1 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant
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