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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 )

Tracking Information
First Submitted Date  ICMJE September 6, 2010
First Posted Date  ICMJE September 9, 2010
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE September 2010
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: IMAB362
Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
Intervention: Drug: IMAB362
Publications * Türeci O, Sahin U, Schulze-Bergkamen H, Zvirbule Z, Lordick F, Koeberle D, Thuss-Patience P, Ettrich T, Arnold D, Bassermann F, Al-Batran SE, Wiechen K, Dhaene K, Maurus D, Gold M, Huber C, Krivoshik A, Arozullah A, Park JW, Schuler M. A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study. Ann Oncol. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)
54
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2010)
25
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Germany,   Latvia,   Lithuania,   Switzerland
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT01197885
Other Study ID Numbers  ICMJE GM-IMAB-001-02
2009-017365-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )
Study Sponsor  ICMJE Ganymed Pharmaceuticals GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Schuler, Prof. Dr. med. Innere Klinik Universitätsklinikum Essen
PRS Account Astellas Pharma Inc
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP