A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer
NCT ID: NCT02443883
Last Updated: 2020-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2015-07-07
2019-06-05
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
NONE
Study Groups
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Ramucirumab Regimen 1
Standard dose of 8 milligram per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
Ramucirumab
Administered IV
Ramucirumab Regimen 2
Experimental dose of 12 mg/kg ramucirumab given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
Ramucirumab
Administered IV
Ramucirumab Regimen 3
Experimental dose of 6 mg/kg ramucirumab given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
Ramucirumab
Administered IV
Ramucirumab Regimen 4
Experimental dose of 8 mg/kg ramucirumab given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
Ramucirumab
Administered IV
Interventions
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Ramucirumab
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participant has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
* The participant received combination chemotherapy prior to disease progression.
* Prior chemotherapy regimens must include a platinum and/or a fluoropyrimidine component and must not include a taxane or antiangiogenic agent.
* The participant has metastatic disease or locally advanced disease that is measurable or nonmeasurable, but is evaluable disease by radiological imaging per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
* Patients are eligible if they are considered not appropriate, for whatever reason, for treatment with ramucirumab in combination with paclitaxel.
* The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The participant has adequate organ function, including:
* Total bilirubin 1.5 × the upper limit of institutional normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 × ULN. If the liver has tumor involvement, AST and ALT \<5 × ULN are acceptable.
* Serum creatinine 1.5 × ULN or calculated creatinine clearance (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection) 60 milliliters/minute (mL/min).
* Urinary protein is \<2+ on dipstick or routine urinalysis.
* Absolute neutrophil count 1.5 × 10\^9/Liter (L), platelets 100 × 10\^9/L, and hemoglobin 9 g/deciliter (dL) (5.58 millimoles/Liter).
* International normalized ratio 1.5 × ULN or prothrombin time 5 seconds above ULN.
* Partial thromboplastin time 5 seconds above ULN.
* The participant has an estimated life expectancy of 12 weeks in the judgment of the investigator.
* The participant, if female and of child-bearing potential, must have a negative serum or urine pregnancy test within 7 days prior to randomization.
Exclusion Criteria
* The participant is receiving chronic therapy with any of the following within 7 days prior to randomization:
* Nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen, naproxen, or similar agents), or
* Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide). Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
* The participant received radiotherapy within 14 days prior to randomization.
* The participant received \>1 line of prior therapy for the treatment of locally advanced and unresectable or metastatic gastric or GEJ (Siewert Types I-III) adenocarcinoma.
* The participant received previous treatment with agents targeting the vascular endothelial growth factor (VEGF)/VEGF receptor 2 signaling pathway.
* The participant has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
* The participant experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
* The participant has symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
* The participant has uncontrolled hypertension, as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, prior to initiating study treatment, despite antihypertensive intervention.
* The participant underwent major surgery within 28 days prior to randomization or central venous access device placement within 7 days prior to randomization.
* The participant has a history of gastrointestinal perforation or fistula within 6 months prior to randomization.
* The participant has any condition (for example, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggests that the participant is, in the investigator's opinion, not an appropriate candidate for the study.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Clinical Research Center
Tucson, Arizona, United States
USC Norris Cancer Hospital
Los Angeles, California, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
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.
Buenos Aires, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Viedma, , Argentina
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Adelaide, , Australia
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Kingswood, , Australia
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Melbourne, , Australia
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Nedlands, , Australia
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Brest, , France
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Créteil, , France
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Dijon, , France
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Lyon, , France
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Paris, , France
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Paris, , France
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Budapest, , Hungary
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Szolnok, , Hungary
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Gdansk, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Baia Mare, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, , Russia
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Kursk, , Russia
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Moscow, , Russia
Leningrad regional clinical hospital
Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Edirne, , Turkey (Türkiye)
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Fatih, , Turkey (Türkiye)
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Medreseboğazı, , Turkey (Türkiye)
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Pendik, , Turkey (Türkiye)
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Cardiff, , United Kingdom
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Exeter, , United Kingdom
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Leeds, , United Kingdom
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Manchester, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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I4T-MC-JVDB
Identifier Type: OTHER
Identifier Source: secondary_id
2014-003791-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15608
Identifier Type: -
Identifier Source: org_study_id
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