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Clinical Trials/EUCTR2006-002727-16-GB
EUCTR2006-002727-16-GB
Active, not recruiting
Phase 1

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 enrollmentMarch 9, 2007
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ConditionsGastric Neoplasm malignantMedDRA version: 8.1 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gastric Neoplasm malignant
Sponsor
Fresenius Biotech GmbH
Enrollment
70
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 9, 2007
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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 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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