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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197885
First Posted: September 9, 2010
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )
  Purpose
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 Intervention Phase
Solid Tumors Drug: IMAB362 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH ):

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]
  • 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)


Enrollment: 54
Study Start Date: September 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Bulgaria
Oncology Dispensary "Dr. Marko Markov"
Varna, Bulgaria, 9002
MHAT "St.Marina"
Varna, Bulgaria, 9010
Complex Oncology Center
Veliko Turnovo, Bulgaria, 5000
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Medizinische Univeritätsklinik Ruhr-Universität Bochum
Bochum, Germany, 44892
Klinikum Braunschweig
Braunschweig, Germany, 38114
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen, Germany, 45122
Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie
Frankfurt, Germany, 60488
Universitätsklinikum Halle
Halle, Germany, 06120
Universitäres Cancer Center Universitätsklinikum Eppendorf
Hamburg, Germany, 20246
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, Germany, 20249
Universitätsklinikum Heidelberg, NCT
Heidelberg, Germany, 69120
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Universitätsmedizin der Johannes-Gutenberg Universität
Mainz, Germany, 55101
Klinikum rechts der Isar
Muenchen, Germany, 81675
Universitätsklinikum Ulm
Ulm, Germany, 89081
Latvia
Piejuras Hospital
Liepaja, Latvia
Paula Stradina Clinical University Hospital
Riga, Latvia, 1002
Riga East Clinical Research
Riga, Latvia, 1038
Lithuania
Vilnius University
Vilnius, Lithuania, 08660
Switzerland
Kantonsspital St. Gallen
St.Gallen, Switzerland, 9007
Sponsors and Collaborators
Ganymed Pharmaceuticals GmbH
Investigators
Principal Investigator: Martin Schuler, Prof. Dr. med. Innere Klinik Universitätsklinikum Essen
  More Information

Responsible Party: Ganymed Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01197885     History of Changes
Other Study ID Numbers: GM-IMAB-001-02
2009-017365-36 ( EudraCT Number )
First Submitted: September 6, 2010
First Posted: September 9, 2010
Last Update Posted: July 2, 2017
Last Verified: December 2015

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs