The purpose of this study is to determine whether ramucirumab is effective treatment in participants with metastatic renal cell carcinoma who have developed progressive disease or become intolerant to tyrosine kinase inhibitor therapy.
The Primary objective is to determine the best objective response rate (ORR) of ramucirumab when administered to participants with metastatic renal cell carcinoma (RCC) whose disease has progressed during therapy with a tyrosine kinase inhibitor (TKI, sunitinib and/or sorafenib) or who have developed intolerance to these agents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Ramucirumab is an injectable solution administered as an intravenous infusion over 1 hour at a dose of 8 mg/kg day 1 of every 14-day cycle.
ImClone Investigational Site
San Francisco, California, United States
ImClone Investigational Site
Chicago, Illinois, United States
ImClone Investigational Site
Metairie, Louisiana, United States
Percentage of Participants With Objective Response (Objective Response Rate)
The percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response during therapy is CR or PR/number of participants treated)\*100.
Time frame: First dose to date of objective progressive disease or death due to any cause (up to 34 months)
Progression-Free Survival
Progression-free survival (PFS) is measured from the date of the first dose to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria or death from any cause. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data for participants whose disease does not progress or for whom no post-baseline assessment is made are censored at the day of their last tumor assessment. Data for participants whose disease does not progress who are subsequently lost to follow-up are also censored at the day of their last tumor assessment.
Time frame: First dose to measured progressive disease or death due to any cause (up to 34 months)
Percentage of Participants Showing Disease Control at Week 12
Participants who were alive and did not experience disease progression were considered to have disease control at 12 weeks. Disease control was based on lack of disease progression using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. According to RECIST criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or detection of new lesion. Participants whose disease progression was symptomatic were not considered to have disease control. The percentage of participants showing disease control=(number of participants who did not have disease or symptomatic progression at Week 12/number of participants treated)\*100.
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ImClone Investigational Site
Boston, Massachusetts, United States
ImClone Investigational Site
Flemington, New Jersey, United States
ImClone Investigational Site
Buffalo, New York, United States
ImClone Investigational Site
Cleveland, Ohio, United States
ImClone Investigational Site
Drexel Hill, Pennsylvania, United States
ImClone Investigational Site
Philadelphia, Pennsylvania, United States
ImClone Investigational Site
Arlington, Texas, United States
...and 1 more locations
Time frame: Week 12 [Cycle 6 (1 cycle=14 days)]
Percentage of Participants With Objective Response (Objective Response Rate) at 12 Weeks
The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at Week 12, as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved at 12 weeks was CR or PR/number of participants treated)\*100.
Time frame: Week 12 [Cycle 6 (1 cycle=14 days)]
Median Duration of Overall Response
Duration of response is the interval from the date of initial documented response \[confirmed complete response (CR) or partial response (PR)\] to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data from participants who did not relapse were censored on the day of their last tumor assessment.
Time frame: Time of first response (CR or PR) to disease progression, initiation of other (or additional) antitumor therapy, or death due to any cause (up to 34 months)
Minimum Concentration (Cmin) of Ramucirumab
Time frame: Immediately prior to the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]
Maximum Concentration (Cmax) of Ramucirumab
Time frame: 1 hour after the end of the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]
Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events
Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
Time frame: First dose to study completion (up to 34 months) plus 30-day safety follow-up