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
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumors | Drug: IMAB362 | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: IMAB362
Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
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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 |
- 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 ]
- 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)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Principal Investigator: | Martin Schuler, Prof. Dr. med. | Innere Klinik Universitätsklinikum Essen |
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 |