Gastric CancerPhase 3RILOMET-2NCT02137343
A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer
A Phase 3 study testing Rilotumumab, Cisplatin and Capecitabine in people with Gastric Cancer, run by Amgen at 25 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Rilotumumab, Cisplatin and Capecitabine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Japan17 sites
Research Site
Akashi-shi, Hyōgo, 673-8558
Research Site
Bunkyo-ku, Tokyo, 113-8677
Research Site
Chiba, Chiba, 260-8717
Research Site
Fukuoka, Fukuoka, 811-1395
Research Site
Kashiwa-shi, Chiba, 277-8577
Research Site
Kawasaki-shi, Kanagawa, 216-8511
Research Site
Kitaadachi-gun, Saitama, 362-0806
Research Site
Matsuyama, Ehime, 791-0280
Research Site
Nagoya, Aichi-ken, 464-8681
Research Site
Osaka, Osaka, 537-8511
Research Site
Osaka, Osaka, 540-0006
Research Site
Osakasayama-shi, Osaka, 589-8511
Research Site
Sapporo, Hokkaido, 060-8648
Research Site
Suita-shi, Osaka, 565-0871
Research Site
Suntou-gun, Shizuoka, 411-8777
Research Site
Takatsuki-shi, Osaka, 569-8686
Research Site
Utsunomiya, Tochigi, 320-0834
South Korea8 sites
Research Site
Goyang-si, Gyeonggi-do, 410-769
Research Site
Hwasun, 519-763
Research Site
Seoul, 110-744
Research Site
Seoul, 120-752
Research Site
Seoul, 135-710
Research Site
Seoul, 136-705
Research Site
Seoul, 137-701
Research Site
Seoul, 138-736
About this study
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
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).
- Conditions
- Gastric Cancer
- Being tested
- Rilotumumab, Placebo, Cisplatin, Capecitabine
- Keywords
- Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilotumumabDrug
Also called AMG102
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.
PlaceboDrug
Placebo
CisplatinDrug
Also called Platinol, Platinal-AQ
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
CapecitabineDrug
Also called Xeloda
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.
| Study group | Role | What they receive |
|---|---|---|
| Rilotumumab | Experimental | Rilotumumab plus Cisplatin and Capecitabine (CX). Receives: Drug: Rilotumumab; Drug: Cisplatin; Drug: Capecitabine |
| Placebo | Placebo comparator | Rilotumumab-placebo plus Cisplatin and Capecitabine (CX). Receives: Drug: Placebo; Drug: Cisplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
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.
Measured: 4 years
Overall Survival
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.
Measured: 4 years
Secondary outcomes (5)
TTP
Time to Progression (TTP)
Measured: 4 years
ORR
Objective Response Rate
Measured: 4 years
DCR
Disease Control Rate
Measured: 4 years
TTR
Time to Response
Measured: 4 years
Incidence of subject adverse events, laboratory abnormalities and immunogenicity
Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137343
- Sponsor's protocol ID
- 20120142
- Acronym
- RILOMET-2
- Status last verified
- Mar 2016
- First submitted
- 28 Apr 2014
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02137343
- Acronym / sponsor ID
- RILOMET-2 / 20120142
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rilotumumab | Experimental | Drug: Rilotumumab, Drug: Cisplatin, Drug: CapecitabineRilotumumab plus Cisplatin and Capecitabine (CX). |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Cisplatin, Drug: CapecitabineRilotumumab-placebo plus Cisplatin and Capecitabine (CX). |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RilotumumabAlso: AMG102Rilotumumab 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. | Drug | Rilotumumab |
| PlaceboPlacebo | Drug | Placebo |
| CisplatinAlso: Platinol, Platinal-AQA platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death) | Drug | Placebo, Rilotumumab |
| CapecitabineAlso: XelodaA chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue. | Drug | Placebo, Rilotumumab |
Primary outcome
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.
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.
5 secondary outcomes
TTP
Time frame: 4 years
ORR
Time frame: 4 years
DCR
Time frame: 4 years
TTR
Time frame: 4 years
Incidence of subject adverse events, laboratory abnormalities and immunogenicity
Time frame: 4 years
Results and safety
The study was stopped early (reason given: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rilotumumab, Cisplatin and Capecitabine in people with Gastric Cancer, run by Amgen at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.