Breast Cancer Clinical Trial
Official title:
A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
Verified date | November 2021 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.
Status | Completed |
Enrollment | 1144 |
Est. completion date | November 19, 2020 |
Est. primary completion date | March 31, 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participant is able to provide signed informed consent - Participant is female and = 18 years of age or older if required by local laws or regulations - Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis - Participant has measurable and/or non-measurable disease - Participants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC) - Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer - Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization - Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization - Participant completed all prior radiotherapy with curative intent = 3 weeks prior to randomization - Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting = 2 weeks prior to randomization - Participant's left ventricular ejection fraction is within normal institutional ranges - Participant has resolution to grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade = 2 - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Participant is amenable to compliance with protocol schedules and testing - Participant has adequate hematological functions [absolute neutrophil count (ANC) = 1500 cells/microliter (mcL), hemoglobin = 9 grams/deciliter (g/dL), and platelets = 100,000 cells/mcL and = 850,000 cells/mcL] - Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 times the upper limit of normal (ULN), or = 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase = 5.0 times the ULN] - Participant has serum creatinine = 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min) - Participant's urinary protein is = 1+ on dipstick or routine urinalysis (UA); if urine protein = 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study - Participant must have adequate coagulation function as defined by international normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices) - Women of childbearing potential must implement adequate contraception in the opinion of the investigator - Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer Exclusion Criteria: - Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years - Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80 - Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF) - Participant has a history of chronic diarrheal disease within 6 months prior to randomization - Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization - Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization - Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders - Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization - Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy - Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator - Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease - Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness - Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen. - Participant is pregnant or lactating |
Country | Name | City | State |
---|---|---|---|
Australia | ImClone Investigational Site | Bankstown | |
Australia | ImClone Investigational Site | Bedford Park | |
Australia | ImClone Investigational Site | Box Hill | |
Australia | ImClone Investigational Site | Darlinghurst | |
Australia | ImClone Investigational Site | East Bentleigh | |
Australia | ImClone Investigational Site | East Melbourne | |
Australia | ImClone Investigational Site | Fitzroy | Victoria |
Australia | ImClone Investigational Site | Frankston | Victoria |
Australia | ImClone Investigational Site | Herston | |
Australia | ImClone Investigational Site | Hobart | |
Australia | ImClone Investigational Site | Milton | |
Australia | ImClone Investigational Site | Nambour | |
Australia | ImClone Investigational Site | New Lambton Heights | |
Australia | ImClone Investigational Site | Perth | |
Australia | ImClone Investigational Site | Ringwood East | |
Australia | ImClone Investigational Site | Subiaco | |
Australia | ImClone Investigational Site | Sydney | |
Australia | ImClone Investigational Site | Tweed Heads | |
Australia | ImClone Investigational Site | Wendouree | |
Belgium | ImClone Investigational Site | Brasschaat | |
Belgium | ImClone Investigational Site | Charleroi | |
Belgium | ImClone Investigational Site | Edegem | |
Belgium | ImClone Investigational Site | Gent | |
Belgium | ImClone Investigational Site | Kortrijk | |
Belgium | ImClone Investigational Site | Liege | |
Belgium | ImClone Investigational Site | Namur | |
Belgium | ImClone Investigational Site | Yvoir | |
Brazil | ImClone Investigational Site | Ijui | |
Brazil | ImClone Investigational Site | Porto Alegre | |
Brazil | ImClone Investigational Site | Porto Alegre | |
Brazil | ImClone Investigational Site | Porto Alegre | |
Brazil | ImClone Investigational Site | Rio de Janeiro | |
Brazil | ImClone Investigational Site | San Paulo | |
Brazil | ImClone Investigational Site | San Paulo | |
Brazil | ImClone Investigational Site | Santo Andre | |
Brazil | ImClone Investigational Site | Sao Paulo | |
Brazil | ImClone Investigational Site | Sao Paulo | |
Brazil | ImClone Investigational Site | Sao Paulo | |
Canada | ImClone Investigational Site | Calgary | Alberta |
Canada | ImClone Investigational Site | Edmonton | Alberta |
Canada | ImClone Investigational Site | Greenfield Park | Quebec |
Canada | ImClone Investigational Site | Quebec | |
Canada | ImClone Investigational Site | Toronto | Ontario |
Canada | ImClone Investigational Site | Vancouver | British Columbia |
Canada | ImClone Investigational Site | Weston | Ontario |
Croatia | ImClone Investigational Site | Osijek | |
Czechia | ImClone Investigational Site | Brno | |
Czechia | ImClone Investigational Site | Kutna Hora | |
Czechia | ImClone Investigational Site | Pardubice | |
Czechia | ImClone Investigational Site | Prague | |
Czechia | ImClone Investigational Site | Prague | |
Czechia | ImClone Investigational Site | Praha | Motol |
Czechia | ImClone Investigational Site | Videnska | |
Egypt | ImClone Investigational Site | Alexandria | |
Egypt | ImClone Investigational Site | Cairo | |
Egypt | ImClone Investigational Site | Cairo | |
Germany | ImClone Investigational Site | Chemnitz | |
Germany | ImClone Investigational Site | Hamburg | |
Germany | ImClone Investigational Site | Hamburg | |
Germany | ImClone Investigational Site | Kiel | |
Germany | ImClone Investigational Site | Lubeck | |
Germany | ImClone Investigational Site | Munchen | |
Germany | ImClone Investigational Site | Munich | |
Germany | ImClone Investigational Site | Oldenburg | |
Germany | ImClone Investigational Site | Saarbrucken | |
Germany | ImClone Investigational Site | Trier | |
Germany | ImClone Investigational Site | Tubingen | |
Ireland | ImClone Investigational Site | Cork | |
Ireland | ImClone Investigational Site | Dublin | |
Ireland | ImClone Investigational Site | Dublin | |
Ireland | ImClone Investigational Site | Erlangen | |
Ireland | ImClone Investigational Site | Limerick | |
Israel | ImClone Investigational Site | Beersheva | |
Israel | ImClone Investigational Site | Jerusalem | |
Israel | ImClone Investigational Site | Petach-Tikva | |
Israel | ImClone Investigational Site | Rehovot | |
Israel | ImClone Investigational Site | Tel Aviv | |
Korea, Republic of | ImClone Investigational Site | Incheon | |
Korea, Republic of | ImClone Investigational Site | Seoul | |
Korea, Republic of | ImClone Investigational Site | Seoul | |
Korea, Republic of | ImClone Investigational Site | Seoul | |
Lebanon | ImClone Investigational Site | Beirut | |
Lebanon | ImClone Investigational Site | Bsalim | |
Lebanon | ImClone Investigational Site | Metn | |
Lebanon | ImClone Investigational Site | Saïda | |
Lebanon | ImClone Investigational Site | Zgharta | |
New Zealand | ImClone Investigational Site | Auckland | |
New Zealand | ImClone Investigational Site | Auckland | |
New Zealand | ImClone Investigational Site | Palmerston North | |
Peru | ImClone Investigational Site | Arequipa | |
Peru | ImClone Investigational Site | Lima | |
Peru | ImClone Investigational Site | Lima | |
Peru | ImClone Investigational Site | Lima | |
Peru | ImClone Investigational Site | Lima | |
Peru | ImClone Investigational Site | Lima | |
Poland | ImClone Investigational Site | Bytom | |
Poland | ImClone Investigational Site | Olsztyn | |
Poland | ImClone Investigational Site | Olsztyn | |
Russian Federation | ImClone Investigational Site | Engels | |
Russian Federation | ImClone Investigational Site | Kazan | |
Russian Federation | ImClone Investigational Site | Kursk | |
Russian Federation | ImClone Investigational Site | Leningrad Region | |
Russian Federation | ImClone Investigational Site | Lipetsk | |
Russian Federation | ImClone Investigational Site | Magnitogorsk | |
Russian Federation | ImClone Investigational Site | Moscow | |
Russian Federation | ImClone Investigational Site | Moscow | |
Russian Federation | ImClone Investigational Site | Moscow | |
Russian Federation | ImClone Investigational Site | Novosibirsk | |
Russian Federation | ImClone Investigational Site | Omsk | |
Russian Federation | ImClone Investigational Site | Orenburg | |
Russian Federation | ImClone Investigational Site | Perm | |
Russian Federation | ImClone Investigational Site | Samara | |
Russian Federation | ImClone Investigational Site | Saratov | |
Russian Federation | ImClone Investigational Site | St. Petersburg | |
Russian Federation | ImClone Investigational Site | St. Petersburg | |
Russian Federation | ImClone Investigational Site | Tambov | |
Russian Federation | ImClone Investigational Site | Ufa | |
Serbia | ImClone Investigational Site | Kragujevac | |
Serbia | ImClone Investigational Site | Nis | |
Serbia | ImClone Investigational Site | Sremska Kamenica | |
Slovakia | ImClone Investigational Site | Bratislava | |
Slovakia | ImClone Investigational Site | Trnava | |
Slovakia | ImClone Investigational Site | Zilina | |
South Africa | ImClone Investigational Site | Amanzimtoti | |
South Africa | ImClone Investigational Site | Bloemfontein | |
South Africa | ImClone Investigational Site | Durban | |
South Africa | ImClone Investigational Site | Durban | |
South Africa | ImClone Investigational Site | Lynnwood | |
South Africa | ImClone Investigational Site | Parktown | Johannesburg |
South Africa | ImClone Investigational Site | Port Elizabeth | |
South Africa | ImClone Investigational Site | Pretoria | |
South Africa | ImClone Investigational Site | Pretoria | |
South Africa | ImClone Investigational Site | Pretoria | |
South Africa | ImClone Investigational Site | Sandton | |
Spain | ImClone Investigational Site | Alicante | |
Spain | ImClone Investigational Site | Badalona | |
Spain | ImClone Investigational Site | Barbastro | |
Spain | ImClone Investigational Site | Barcelona | |
Spain | ImClone Investigational Site | Barcelona | |
Spain | ImClone Investigational Site | Girona | |
Spain | ImClone Investigational Site | Jaen | |
Spain | ImClone Investigational Site | La Coruna | |
Spain | ImClone Investigational Site | La Laguna - Tenerife | |
Spain | ImClone Investigational Site | Lleida | |
Spain | ImClone Investigational Site | Madrid | |
Spain | ImClone Investigational Site | Madrid | |
Spain | ImClone Investigational Site | Madrid | |
Spain | ImClone Investigational Site | Madrid | |
Spain | ImClone Investigational Site | Madrid | |
Spain | ImClone Investigational Site | Malaga | |
Spain | ImClone Investigational Site | Palma de Mallorca | |
Spain | ImClone Investigational Site | Salamanca | |
Spain | ImClone Investigational Site | San Sebastian | |
Spain | ImClone Investigational Site | Santander | |
Spain | ImClone Investigational Site | Sevilla | |
Spain | ImClone Investigational Site | Toledo | |
Spain | ImClone Investigational Site | Valencia | |
Spain | ImClone Investigational Site | Valencia | |
Spain | ImClone Investigational Site | Zaragoza | |
Taiwan | ImClone Investigational Site | Changhua | |
Taiwan | ImClone Investigational Site | Taipei | |
Taiwan | ImClone Investigational Site | Taoyuan County | |
United Kingdom | ImClone Investigational Site | Bournemouth | |
United Kingdom | ImClone Investigational Site | Edinburgh | |
United Kingdom | ImClone Investigational Site | Huddersfield | |
United Kingdom | ImClone Investigational Site | Hull | |
United Kingdom | ImClone Investigational Site | Manchester | |
United Kingdom | ImClone Investigational Site | Nottingham | |
United States | ImClone Investigational Site | Alhambra | California |
United States | ImClone Investigational Site | Alton | Illinois |
United States | ImClone Investigational Site | Atlanta | Georgia |
United States | ImClone Investigational Site | Atlanta | Georgia |
United States | ImClone Investigational Site | Aurora | Colorado |
United States | ImClone Investigational Site | Bakersfield | California |
United States | ImClone Investigational Site | Bartlett | Tennessee |
United States | ImClone Investigational Site | Birmingham | Alabama |
United States | ImClone Investigational Site | Bismarck | North Dakota |
United States | ImClone Investigational Site | Chandler | Arizona |
United States | ImClone Investigational Site | Charlotte | North Carolina |
United States | ImClone Investigational Site | Charlotte | North Carolina |
United States | ImClone Investigational Site | Charlotte | North Carolina |
United States | ImClone Investigational Site | Charlotte | North Carolina |
United States | ImClone Investigational Site | Charlotte | North Carolina |
United States | ImClone Investigational Site | Charlotte | North Carolina |
United States | ImClone Investigational Site | Chicago | Illinois |
United States | ImClone Investigational Site | Chicago | Illinois |
United States | ImClone Investigational Site | Chula Vista | California |
United States | ImClone Investigational Site | Elkhart | Indiana |
United States | ImClone Investigational Site | Fort Lauderdale | Florida |
United States | ImClone Investigational Site | Gainesville | Florida |
United States | ImClone Investigational Site | Germantown | Tennessee |
United States | ImClone Investigational Site | Gilbert | Arizona |
United States | ImClone Investigational Site | Grand Island | Nebraska |
United States | ImClone Investigational Site | Henderson | Nevada |
United States | ImClone Investigational Site | Kearney | Nebraska |
United States | ImClone Investigational Site | La Mesa | California |
United States | ImClone Investigational Site | Lansing | Michigan |
United States | ImClone Investigational Site | Lexington | Kentucky |
United States | ImClone Investigational Site | Los Angeles | California |
United States | ImClone Investigational Site | Lubbock | Texas |
United States | ImClone Investigational Site | Macon | Georgia |
United States | ImClone Investigational Site | Marietta | Georgia |
United States | ImClone Investigational Site | Memphis | Tennessee |
United States | ImClone Investigational Site | Memphis | Tennessee |
United States | ImClone Investigational Site | Memphis | Tennessee |
United States | ImClone Investigational Site | Mesa | Arizona |
United States | ImClone Investigational Site | Minneapolis | Minnesota |
United States | ImClone Investigational Site | Mishawaka | Indiana |
United States | ImClone Investigational Site | Mobile | Alabama |
United States | ImClone Investigational Site | New Port Richey | Florida |
United States | ImClone Investigational Site | New York | New York |
United States | ImClone Investigational Site | Niles | Tennessee |
United States | ImClone Investigational Site | Oceanside | California |
United States | ImClone Investigational Site | Oklahoma City | Oklahoma |
United States | ImClone Investigational Site | Oxford | Tennessee |
United States | ImClone Investigational Site | Pasadena | California |
United States | ImClone Investigational Site | Pasadena | California |
United States | ImClone Investigational Site | Portland | Oregon |
United States | ImClone Investigational Site | Saint Joseph | Michigan |
United States | ImClone Investigational Site | Saint Louis | Missouri |
United States | ImClone Investigational Site | Salt Lake City | Utah |
United States | ImClone Investigational Site | San Diego | California |
United States | ImClone Investigational Site | Santa Barbara | California |
United States | ImClone Investigational Site | Santa Maria | California |
United States | ImClone Investigational Site | Santa Monica | California |
United States | ImClone Investigational Site | Skokie | Illinois |
United States | ImClone Investigational Site | Solvang | California |
United States | ImClone Investigational Site | South Bend | Indiana |
United States | ImClone Investigational Site | Southaven | Mississippi |
United States | ImClone Investigational Site | Temple | Texas |
United States | ImClone Investigational Site | Valencia | California |
United States | ImClone Investigational Site | West Reading | Pennsylvania |
United States | ImClone Investigational Site | Westville | Indiana |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Australia, Belgium, Brazil, Canada, Croatia, Czechia, Egypt, Germany, Ireland, Israel, Korea, Republic of, Lebanon, New Zealand, Peru, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) | PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after =2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression. | Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months) | |
Secondary | Overall Survival (OS) | OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. | Randomization to death or until data cutoff of 29-May-2015 (up to 82 months) | |
Secondary | Time to Progression (TTP) | TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression. | Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months) | |
Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate) | Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions. | Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months) | |
Secondary | Duration of Response | Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as =30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as =20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of =1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after =2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression. | Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 56 months) | |
Secondary | Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy | FACT-B measures the following domains of health-related quality of life (HR-QoL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL. | Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 56 months) | |
Secondary | Number of Participants With Adverse Events | Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module. | First dose to study completion (up to 12.3 years) | |
Secondary | Immunogenicity: Percentage of Participants With Treatment Emergent Anti-Ramucirumab Antibodies Until Primary Data Cutoff of 31-Mar-2013 | Percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals. | Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event up to 56 months | |
Secondary | Immunogenicity: Percentage of Participants Available After 31-Mar-2013 With Treatment Emergent Anti-Ramucirumab Antibodies Until Data Cutoff From 01-Apr-2013 to 08-Sep-2016 | Percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals. | Follow-up from 01-Apr-2013 to 08-Sep-2016 (Up to 56 -97 months) |
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