Clinical trial NCT01197885: Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of remission (CR, PR) according to RECIST Criteria
timeFrame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Secondary outcomes:
measure: Number of Participants with adverse events as a measure of safety and tolerability
timeFrame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
measure: Frequency and severity of adverse events according to CTCAE v3.0
timeFrame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
measure: Progression-free-survival time (PFS)
timeFrame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Other outcomes:
Locations:
city: Varna
country: Bulgaria
facility: Oncology Dispensary "Dr. Marko Markov"
city: Varna
country: Bulgaria
facility: MHAT "St.Marina"
city: Veliko Turnovo
country: Bulgaria
facility: Complex Oncology Center
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Medizinische Univeritätsklinik Ruhr-Universität Bochum
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Hamburg
country: Germany
facility: Universitäres Cancer Center Universitätsklinikum Eppendorf
city: Hamburg
country: Germany
facility: Onkologische Schwerpunktpraxis Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, NCT
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes-Gutenberg Universität
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Liepaja
country: Latvia
facility: Piejuras Hospital
city: Riga
country: Latvia
facility: Paula Stradina Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical Research
city: Vilnius
country: Lithuania
facility: Vilnius University
city: St.Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: Innere Klinik Universitätsklinikum Essen
name: Martin Schuler, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tureci 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.