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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197885
• Other study ID #: GM-IMAB-001-02
• Secondary ID: 2009-017365-36
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2010
• Last updated: June 30, 2017
• Start date: September 2010
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Bulgaria	MHAT "St.Marina"	Varna
Bulgaria	Oncology Dispensary "Dr. Marko Markov"	Varna
Bulgaria	Complex Oncology Center	Veliko Turnovo
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Medizinische Univeritätsklinik Ruhr-Universität Bochum	Bochum
Germany	Klinikum Braunschweig	Braunschweig
Germany	Universitätsklinikum Essen, Innere Klinik (Tumorforschung)	Essen
Germany	Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie	Frankfurt
Germany	Universitätsklinikum Halle	Halle
Germany	Onkologische Schwerpunktpraxis Eppendorf	Hamburg
Germany	Universitäres Cancer Center Universitätsklinikum Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg, NCT	Heidelberg
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsmedizin der Johannes-Gutenberg Universität	Mainz
Germany	Klinikum rechts der Isar	Muenchen
Germany	Universitätsklinikum Ulm	Ulm
Latvia	Piejuras Hospital	Liepaja
Latvia	Paula Stradina Clinical University Hospital	Riga
Latvia	Riga East Clinical Research	Riga
Lithuania	Vilnius University	Vilnius
Switzerland	Kantonsspital St. Gallen	St.Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Ganymed Pharmaceuticals GmbH

Countries where clinical trial is conducted

Bulgaria,  Germany,  Latvia,  Lithuania,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of remission (CR, PR) according to RECIST Criteria		All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Secondary	Number of Participants with adverse events as a measure of safety and tolerability		All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Secondary	Frequency and severity of adverse events according to CTCAE v3.0		All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Secondary	Progression-free-survival time (PFS)	The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first)	All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion