check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
16091
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Nexavar as first targeted therapy in patients with advanced renal cell carcinoma
Trial purpose
This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.
Key Participants Requirements
Sex
BothAge
0 - N/ATrial summary
Enrollment Goal
20Trial Dates
July 2012 - December 2013Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany |
Primary Outcome
- Duration of Nexavar treatmentdate_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Overall Survival (OS)date_rangeTime Frame:1 - 1.5 years after LPLVenhanced_encryptionNoSafety Issue:
- Health related quality of life (HRQoL)date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- Progression-free survival (PFS)date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- Tumor status, of patients will be evaluated according to the categories “Complete Response”, “Partial Response”, “Stable Disease”, “Clinical Progression”, “Radiological Progression”.date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- Incidence of Treatment-emergent Adverse Events (TEAE)date_rangeTime Frame:up to 3 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A