Stomach CancerPhase 2NCT01246960
A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer
A Phase 2 study testing Ramucirumab, Oxaliplatin and Leucovorin in people with Stomach Cancer and Esophageal Cancer, run by Eli Lilly and Company at 58 sites in United States.
Trial summary
The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer, Esophageal Cancer
- What is being tested?
- Ramucirumab, Oxaliplatin and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 58 sitesUnited States
- Study dates
- Apr 2011to May 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic confirmation of adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or stomach
- Metastatic or locally advanced, unresectable disease at time of study entry
- Provided signed informed consent and is amenable to compliance with protocol schedules and testing
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry
- Adequate renal, hematological, and hepatic function
- Measurable or non-measurable disease at the time of study entry
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- Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy, except where otherwise mentioned in the eligibility criteria
- Eligible participants of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy
- Life expectancy of greater than or equal to 3 months
- Willingness to provide blood and tissue samples for research purposes. Submission of tumor specimen is mandatory for participation in this study, if a histologic, paraffin-embedded specimen exists (either from a surgical resection or biopsy); submission of paraffin block or a minimum of 8 unstained slides is required if sufficient sample. NOTE: If insufficient additional tissue exists (that is, all tissue has been utilized for prior diagnostic purposes), participation in the study is allowable without the requirement for an additional biopsy; this situation must be discussed with the study principal investigator and/or the ImClone medical monitor or designee.
Who cannot join
- The participant has received prior first-line systemic therapy for advanced/unresectable and/or metastatic disease (prior adjuvant or neo-adjuvant therapy is permitted)
- Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to study entry
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant ineligible for entry into this study
- The participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted.
- The participant has significant third-space fluid retention (for example, ascites or pleural effusion), and is not amenable for required repeated drainage
- The participant is pregnant or breastfeeding
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- Uncontrolled intercurrent illness including, but not limited to, active or uncontrolled clinically serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled thromboembolic, or hemorrhagic disorder, psychiatric illness/social situations, or other co-morbid systemic illnesses, or other severe concurrent disease
- Immunocompromised participants including participants known to be human immunodeficiency virus (HIV) positive.
- Progressive disease less than or equal to 12 months of completing platinum or 5-FU treatment, including capecitabine, if given previously in the perioperative (adjuvant or neoadjuvant) setting
- Current or recent (within 28 days prior to randomization) treatment with an investigational drug that has not received regulatory approval for any indication at the time of study entry, or participation in another interventional clinical trial. Participants participating in surveys or observational studies are eligible to participate in this study.
- Are currently enrolled in, or discontinued within the last 28 days from, a clinical trial involving ramucirumab drug product (DP), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Received prior therapy with an antiangiogenic agent (including but not limited to bevacizumab, sunitinib, or sorafenib)
- Major surgical procedure or significant traumatic injury less than 28 days prior to randomization, or anticipation of need for elective or planned major surgical procedure during the course of the study. Subcutaneous venous access device placement within 7 days prior to randomization
- Clinically significant peripheral neuropathy at the time of registration
- Known central nervous system metastases that are symptomatic or untreated
- New York Heart Association (NYHA) classification III-IV congestive heart failure
- Greater than normal risk of bleeding or coagulopathy in the absence of therapeutic anticoagulation; Grade 3/4 gastrointestinal bleeding within 3 months prior to registration; active bleeding (that is, within 14 days prior to first dose of study therapy); or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
- Participant has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, stroke, transient ischemic attack (TIA), cerebrovascular accident, or unstable angina, less than or equal to 6 months prior to registration
- Clinically significant vascular disease (for example, aortic aneurysm, aortic dissection) for which more than minimal intervention is being administered or planned
- History of hypertensive crisis or hypertensive encephalopathy or current poorly-controlled hypertension despite standard medical management
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess less than 6 months prior to registration
- Known hypersensitivity to any of the treatment components of modified FOLFOX6 (mFOLFOX6) (oxaliplatin, 5-FU, and leucovorin) or ramucirumab DP
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 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.
Alhambra, California, 91801
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Anchorage, Alaska, 99508
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Ann Arbor, Michigan, 48106
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Bakersfield, California, 93309
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Baltimore, Maryland, 21201
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Billings, Montana, 59101
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Bozeman, Montana, 59715
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Burlington, Massachusetts, 01805
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Charleston, South Carolina, 29425
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Chattanooga, Tennessee, 37404
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Cincinnati, Ohio, 45242
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Columbia, South Carolina, 29210
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Danville, Pennsylvania, 17822
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Dayton, Ohio, 45420
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Denver, Colorado, 80218
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Detroit, Michigan, 48201
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Duluth, Minnesota, 55805
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Dunmore, Pennsylvania, 18512
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Englewood, Florida, 34223
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Fullerton, California, 92835
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Grand Junction, Colorado, 81501
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Grand Rapids, Michigan, 49503
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Hackensack, New Jersey, 07601
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Kalamazoo, Michigan, 49007
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Kirkland, Washington, 98034
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Las Vegas, Nevada, 89169
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Lewiston, Maine, 04240
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Los Angeles, California, 90024
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Madison, Wisconsin, 53792
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Marshfield, Wisconsin, 54449
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Mount Vernon, Washington, 98273
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Nashville, Tennessee, 37203
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New Orleans, Louisiana, 70121
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Northridge, California, 91325
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Oklahoma City, Oklahoma, 73104
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Omaha, Nebraska, 68106
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Pembroke Pines, Florida, 33028
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Philadelphia, Pennsylvania, 19141
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Redondo Beach, California, 90277
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Richmond, Virginia, 23230
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Rochester, Minnesota, 55905
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Saint Louis Park, Minnesota, 55416
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Salt Lake City, Utah, 84112
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Santa Barbara, California, 93105
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Santa Monica, California, 93454
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Scottsdale, Arizona, 85259
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Seattle, Washington, 98112
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Sioux City, Iowa, 51101
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Spartanburg, South Carolina, 29303
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Springfield, Massachusetts, 01107
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St Louis, Missouri, 63110
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Tacoma, Washington, 98405
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Terre Haute, Indiana, 47802
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The Bronx, New York, 10467
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Washington D.C., District of Columbia, 20007
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Wenatchee, Washington, 98801
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West Palm Beach, Florida, 33401
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Wichita, Kansas, 67214
About this study
Official title: Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product(IMC-1121B) Versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach
The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.
- Conditions
- Stomach Cancer, Esophageal Cancer
- Being tested
- Ramucirumab, Placebo, Oxaliplatin, Leucovorin, 5-Fluorouracil
- Keywords
- cancer, stomach, esophagus, gastroesophageal
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabBiological
Also called LY3009806, IMC-1121B
Administered intravenously
PlaceboDrug
Administered intravenously
OxaliplatinDrug
Administered intravenously
LeucovorinDrug
Administered intravenously
5-FluorouracilDrug
Also called 5-FU
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab | Experimental | * Oxaliplatin 85 milligrams per square meter (mg/m^2) given on Day 1 of a 2-week cycle
* Leucovorin 400 mg/m^2 given on Day 1 of a 2-week cycle
* 5-Fluorouracil (5-FU) 400 mg/m^2 bolus given on Day 1 of a 2-week cycle
* 5-FU 2400 mg/m^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle
* Ramucirumab 8 milligrams per kilogram (mg/kg) given on Day 1 of a 2-week cycle
Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met Receives: Biological: Ramucirumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil |
| Placebo | Placebo comparator | * Oxaliplatin 85 mg/m^2 given on Day 1 of a 2-week cycle
* Leucovorin 400 mg/m^2 given on Day 1 of a 2-week cycle
* 5-FU 400 mg/m^2 bolus given on Day 1 of a 2-week cycle
* 5-FU 2400 mg/m^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle
* Placebo given on Day 1 of a 2-week cycle
Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met Receives: Drug: Placebo; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined using Response Evaluation Criteria in Solid Tumors [RECIST version (v.) 1.1] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.
Measured: Randomization to measured PD or date of death from any cause (up to Month 25.0)
Secondary outcomes (5)
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.
Measured: Randomization to date of death from any cause (up to Month 28.3)
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)*100.
Measured: Randomization to measured PD (up to Month 23.0)
Duration of Response
Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.
Measured: Time of first response to measured PD (up to Month 23.0)
Time to Disease Progression (TTP)
TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.
Measured: Randomization to measured PD (up to Month 25.0)
Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Measured: Months 1, 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionMay 2014
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 Stomach 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246960
- Sponsor's protocol ID
- 14057
- Other IDs
- I4T-MC-JVBT
- Status last verified
- Oct 2014
- First submitted
- 8 Nov 2010
- Last updated
- 8 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yoon HH, Bendell JC, Braiteh FS, Firdaus I, Philip PA, Cohn AL, Lewis N, Anderson DM, Arrowsmith E, Schwartz JD, Gao L, Hsu Y, Xu Y, Ferry D, Alberts SR, Wainberg ZA. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016 Dec;27(12):2196-2203. doi: 10.1093/annonc/mdw423. Epub 2016 Oct 20.
PubMed 27765757
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product(IMC-1121B) Versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach
- ClinicalTrials.gov ID
- NCT01246960
- Acronym / sponsor ID
- 14057
- Conditions
- Stomach Cancer, Esophageal Cancer
- Keywords
- cancer, stomach, esophagus, gastroesophageal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Posted 8 Oct 2014
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 determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab | Experimental | Biological: Ramucirumab, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-Fluorouracil* Oxaliplatin 85 milligrams per square meter (mg/m^2) given on Day 1 of a 2-week cycle * Leucovorin 400 mg/m^2 given on Day 1 of a 2-week cycle * 5-Fluorouracil (5-FU) 400 mg/m^2 bolus given on Day 1 of a 2-week cycle * 5-FU 2400 mg/m^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle * Ramucirumab 8 milligrams per kilogram (mg/kg) given on Day 1 of a 2-week cycle Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-Fluorouracil* Oxaliplatin 85 mg/m^2 given on Day 1 of a 2-week cycle * Leucovorin 400 mg/m^2 given on Day 1 of a 2-week cycle * 5-FU 400 mg/m^2 bolus given on Day 1 of a 2-week cycle * 5-FU 2400 mg/m^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle * Placebo given on Day 1 of a 2-week cycle Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic or cytologic confirmation of adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or stomach
- Metastatic or locally advanced, unresectable disease at time of study entry
- Provided signed informed consent and is amenable to compliance with protocol schedules and testing
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry
- Adequate renal, hematological, and hepatic function
Key exclusion criteria (22 listed)
- The participant has received prior first-line systemic therapy for advanced/unresectable and/or metastatic disease (prior adjuvant or neo-adjuvant therapy is permitted)
- Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to study entry
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant ineligible for entry into this study
- The participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted.
- The participant has significant third-space fluid retention (for example, ascites or pleural effusion), and is not amenable for required repeated drainage
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 intravenously | Biological | Ramucirumab |
| PlaceboAdministered intravenously | Drug | Placebo |
| OxaliplatinAdministered intravenously | Drug | Placebo, Ramucirumab |
| LeucovorinAdministered intravenously | Drug | Placebo, Ramucirumab |
| 5-FluorouracilAlso: 5-FUAdministered intravenously | Drug | Placebo, Ramucirumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Randomization to measured PD or date of death from any cause (up to Month 25.0)
PFS was defined using Response Evaluation Criteria in Solid Tumors [RECIST version (v.) 1.1] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.
5 secondary outcomes
Overall Survival (OS)
Time frame: Randomization to date of death from any cause (up to Month 28.3)
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
Time frame: Randomization to measured PD (up to Month 23.0)
Duration of Response
Time frame: Time of first response to measured PD (up to Month 23.0)
Time to Disease Progression (TTP)
Time frame: Randomization to measured PD (up to Month 25.0)
Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Time frame: Months 1, 2, 4, 6, and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27765757Yoon HH, Bendell JC, Braiteh FS, Firdaus I, Philip PA, Cohn AL, Lewis N, Anderson DM, Arrowsmith E, Schwartz JD, Gao L, Hsu Y, Xu Y, Ferry D, Alberts SR, Wainberg ZA. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016 Dec;27(12):2196-2203. doi: 10.1093/annonc/mdw423. Epub 2016 Oct 20.
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
58 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, Oxaliplatin and Leucovorin in people with Stomach Cancer and Esophageal Cancer, run by Eli Lilly and Company at 58 sites in United States.
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 22 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 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States. 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 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 8 Oct 2014). 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?
Progression-Free Survival (PFS) (time frame: Randomization to measured PD or date of death from any cause (up to Month 25.0)). 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 NCT01246960, 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 8 Oct 2014.