The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Administered IV
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
The Cmin is the minimum observed serum concentration of ramucirumab.
Time frame: Day 29, 43, 71 and 85: predose
Immunogenicity: Number of Participants With Anti-Ramucirumab Antibodies
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
Time frame: Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months)
Rate of Progression Free Survival (PFS) at the First 6-Week Tumor Assessment
PFS defined as the time from first day of therapy to first evidence of disease progression per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) or death from any cause up to the first 6-week tumor assessment. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study and absolute increase of at least 5 mm.Appearance of 1 or more new lesions was also considered progression. Nontarget PD is unequivocal progression of existing nontarget lesions.Appearance of 1 or more new nontarget lesions was also considered PD.Participants with no baseline disease assessment: PFS time was censored at the randomization date,regardless of whether or not objectively determined disease progression or death has been observed.
Time frame: Baseline until the first 6-week tumor assessment
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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
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.
Viedma, Argentina
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.
Adelaide, Australia
...and 35 more locations