A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer
NCT ID: NCT02137343
Last Updated: 2016-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
34 participants
INTERVENTIONAL
2014-07-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
Rilotumumab
Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
Cisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
Capecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Placebo
Placebo
Cisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
Capecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Interventions
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Rilotumumab
Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
Placebo
Placebo
Cisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
Capecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
* Tumor MET-positive by immunohistochemistry (IHC).
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Male or female subject greater than or equal to 20 years of age at the time of informed consent.
Exclusion Criteria
* Previous systemic therapy for locally advanced or metastatic gastric or GEJ or lower esophageal adenocarcinoma.
* Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization.
* Squamous cell histology.
20 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Kashiwa-shi, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi-shi, Hyōgo, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Osakasayama-shi, Osaka, Japan
Research Site
Suita-shi, Osaka, Japan
Research Site
Takatsuki-shi, Osaka, Japan
Research Site
Kitaadachi-gun, Saitama, Japan
Research Site
Suntou-gun, Shizuoka, Japan
Research Site
Utsunomiya, Tochigi, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Goyang-si, Gyeonggi-do, , South Korea
Research Site
Hwasun, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120142
Identifier Type: -
Identifier Source: org_study_id
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