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A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer (RILOMET-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137343
Recruitment Status : Terminated (All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.)
First Posted : May 13, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Rilotumumab Drug: Placebo Drug: Cisplatin Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Study Start Date : July 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
Drug: 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.
Other Name: AMG102

Drug: 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)
Other Names:
  • Platinol
  • Platinal-AQ

Drug: 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 Name: Xeloda

Placebo Comparator: Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Drug: Placebo
Placebo

Drug: 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)
Other Names:
  • Platinol
  • Platinal-AQ

Drug: 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 Name: Xeloda




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 4 years ]
    To determine if the treatment of rilotumumab in combination with CX significantly improves progression-free survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.

  2. Overall Survival [ Time Frame: 4 years ]
    To determine if the treatment of rilotumumab in combination with CX significantly improves overall survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.


Secondary Outcome Measures :
  1. TTP [ Time Frame: 4 years ]
    Time to Progression (TTP)

  2. ORR [ Time Frame: 4 years ]
    Objective Response Rate

  3. DCR [ Time Frame: 4 years ]
    Disease Control Rate

  4. TTR [ Time Frame: 4 years ]
    Time to Response

  5. Incidence of subject adverse events, laboratory abnormalities and immunogenicity [ Time Frame: 4 years ]
    Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma.
  • 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.

Key Exclusion Criteria:

  • Human epidermal growth factor receptor 2 (HER2)-overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma.
  • 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.

Information from the National Library of Medicine

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): NCT02137343


Locations
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Japan
Research Site
Nagoya-shi, Aichi, Japan, 464-8681
Research Site
Chiba-shi, Chiba, Japan, 260-8717
Research Site
Kashiwa-shi, Chiba, Japan, 277-8577
Research Site
Matsuyama-shi, Ehime, Japan, 791-0280
Research Site
Fukuoka-shi, Fukuoka, Japan, 811-1395
Research Site
Sapporo-shi, Hokkaido, Japan, 060-8648
Research Site
Akashi-shi, Hyogo, Japan, 673-8558
Research Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Research Site
Osaka-shi, Osaka, Japan, 537-8511
Research Site
Osaka-shi, Osaka, Japan, 540-0006
Research Site
Osakasayama-shi, Osaka, Japan, 589-8511
Research Site
Suita-shi, Osaka, Japan, 565-0871
Research Site
Takatsuki-shi, Osaka, Japan, 569-8686
Research Site
Kitaadachi-gun, Saitama, Japan, 362-0806
Research Site
Suntou-gun, Shizuoka, Japan, 411-8777
Research Site
Utsunomiya-shi, Tochigi, Japan, 320-0834
Research Site
Bunkyo-ku, Tokyo, Japan, 113-8677
Korea, Republic of
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Research Site
Hwasun, Korea, Republic of, 519-763
Research Site
Seoul, Korea, Republic of, 110-744
Research Site
Seoul, Korea, Republic of, 120-752
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Seoul, Korea, Republic of, 136-705
Research Site
Seoul, Korea, Republic of, 137-701
Research Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02137343    
Other Study ID Numbers: 20120142
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Keywords provided by Amgen:
Gastric Cancer
First Line Treatment Gastroesophageal Junction (GEJ)
Gastroesophageal Junction Cancer (GEJ)
GEJ Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Rilotumumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological