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Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer

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ClinicalTrials.gov Identifier: NCT01197885
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )

Study Description
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Brief Summary:
IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: IMAB362 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
Study Start Date : September 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: IMAB362
Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
 Drug: IMAB362
Cohort 1 repeated doses of 300 mg/m2 Cohort 2 repeated doses of 600 mg/m2 Cohort 3 doses to be determined, 600mg/m2 or less


Outcome Measures
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Primary Outcome Measures :
  1. Rate of remission (CR, PR) according to RECIST Criteria [ Time Frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion ]

Secondary Outcome Measures :
  1. Number of Participants with adverse events as a measure of safety and tolerability [ Time Frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion ]
  2. Frequency and severity of adverse events according to CTCAE v3.0 [ Time Frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion ]
  3. Progression-free-survival time (PFS) [ Time Frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion ]
    The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
  • CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
  • At least 1 measurable site of disease according to RECIST criteria

Exclusion Criteria:

  • Less than 3 weeks since prior chemo-or radiation therapy
  • Other concurrent anticancer therapies
  • Concurrent anticoagulation with vitamin K antagonists
  • Therapeutic doses of Heparin (prophylactic doses accepted)
  • Uncontrolled or severe illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197885


Locations
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Sponsors and Collaborators
Ganymed Pharmaceuticals GmbH
Investigators
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Principal Investigator: Martin Schuler, Prof. Dr. med. Innere Klinik Universitätsklinikum Essen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ganymed Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01197885    
Other Study ID Numbers: GM-IMAB-001-02
2009-017365-36 ( EudraCT Number )
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: December 2015