Gastric CancerPhase 2NCT01983878
A Study of Ramucirumab in Treating Japanese Participants With Metastatic Gastric or Gastroesophageal Junction Cancer
A Phase 2 study testing Ramucirumab in people with Gastric Cancer, run by Eli Lilly and Company at 11 sites in Japan.
Trial summary
The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Ramucirumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 11 sitesJapan
- Study dates
- Dec 2013to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma
- Metastatic disease or locally recurrent, unresectable disease
- Measurable disease and/or evaluable disease
- Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
- Life expectancy of at least 3 months
- Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
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- Eastern Cooperative Oncology Group performance status score of 0-1
- Has adequate organ function
- Must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods), if sexually active
- Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment
Who cannot join
- Documented and/or symptomatic brain or leptomeningeal metastases
- Bone metastases
- Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
- Experienced any arterial thromboembolic event within 6 months prior to enrollment
- Ongoing or active significant infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator
- Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements
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- Blood pressure in abnormal range despite standard medical management
- Has a serious or nonhealing wound, ulcer, or bone fracture
- Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer
- Received any investigational therapy within 30 days prior to enrollment
- Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
- Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor 2 (VEGFR-2) activity (including bevacizumab), or any anti-angiogenic agent
- Receiving chronic therapy with nonsteroidal anti-inflammatory drugs or receiving other antiplatelet agents. Aspirin use at doses up to 325 milligrams per day is permitted
- Has elective or planned major surgery to be performed during the course of the clinical study
- Has a known allergy to any of the treatment components
- Pregnant or breastfeeding
- Have positive test results for human immunodeficiency virus, hepatitis B, or hepatitis C antibodies
- Known alcohol or drug dependency
- Previous or concurrent malignancy except for basal or squamous cell skin cancer (nonmelanoma) and/or pre-invasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment
- Currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, 464-8681
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, 260-8717
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ehime, 791-0280
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, 060-8648
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyōgo, 650-0047
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, 224-8503
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, 558-8558
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, 569-8686
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saitama, 362-0806
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shizuoka, 411-8777
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, 181-8611
About this study
Official title: A Phase 2 Study of Ramucirumab in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First Line Platinum- or Fluoropyrimidine-Containing Combination Therapy in Japanese Patients
The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.
- Conditions
- Gastric Cancer
- Being tested
- Ramucirumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
Also called LY3009806, IMC-1121B
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab | Experimental | Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance or withdrawal of consent. Receives: Drug: Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)
The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.
Measured: 12 Weeks
Secondary outcomes (7)
Progression-Free Survival (PFS)
The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first.
Measured: Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100.
Measured: Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)
Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]
Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100.
Measured: Baseline to Measured PD or Death from Any Cause (Up to 12 Months)
Overall Survival (OS)
The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.
Measured: Baseline to Death from Any Cause (Up to 13 Months)
Number of Participants With Anti-Ramucirumab Antibodies
A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.
Measured: Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
Measured: Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose
PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
Measured: Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983878
- Sponsor's protocol ID
- 15045
- Other IDs
- I4T-JE-JVCL
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2013
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Yamaguchi K, Fujitani K, Nagashima F, Omuro Y, Machida N, Nishina T, Koue T, Tsujimoto M, Maeda K, Satoh T. Ramucirumab for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first-line platinum- or fluoropyrimidine-containing combination therapy in Japanese patients: a phase 2, open-label study. Gastric Cancer. 2018 Nov;21(6):1041-1049. doi: 10.1007/s10120-018-0811-4. Epub 2018 Mar 5.
PubMed 29508095
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Ramucirumab in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First Line Platinum- or Fluoropyrimidine-Containing Combination Therapy in Japanese Patients
- ClinicalTrials.gov ID
- NCT01983878
- Acronym / sponsor ID
- 15045
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Posted 22 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab | Experimental | Drug: RamucirumabRamucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance or withdrawal of consent. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma
- Metastatic disease or locally recurrent, unresectable disease
- Measurable disease and/or evaluable disease
- Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
- Life expectancy of at least 3 months
Key exclusion criteria (20 listed)
- Documented and/or symptomatic brain or leptomeningeal metastases
- Bone metastases
- Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
- Experienced any arterial thromboembolic event within 6 months prior to enrollment
- Ongoing or active significant infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator
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 |
|---|---|---|
| RamucirumabAlso: LY3009806, IMC-1121BAdministered IV | Drug | Ramucirumab |
Primary outcome
Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)
Time frame: 12 Weeks
The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.
7 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Time frame: Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)
Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]
Time frame: Baseline to Measured PD or Death from Any Cause (Up to 12 Months)
Overall Survival (OS)
Time frame: Baseline to Death from Any Cause (Up to 13 Months)
Number of Participants With Anti-Ramucirumab Antibodies
Time frame: Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
Time frame: Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose
PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
Time frame: Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29508095Yamaguchi K, Fujitani K, Nagashima F, Omuro Y, Machida N, Nishina T, Koue T, Tsujimoto M, Maeda K, Satoh T. Ramucirumab for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first-line platinum- or fluoropyrimidine-containing combination therapy in Japanese patients: a phase 2, open-label study. Gastric Cancer. 2018 Nov;21(6):1041-1049. doi: 10.1007/s10120-018-0811-4. Epub 2018 Mar 5.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) study director
Eli Lilly and Company
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramucirumab in people with Gastric Cancer, run by Eli Lilly and Company at 11 sites in Japan.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983878, which also lists 1 linked publication.
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 30 Sep 2019.