A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®
PONDIAC
Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions
2 other identifiers
observational
71
1 country
1
Brief Summary
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 15, 2012
June 1, 2012
October 9, 2008
June 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated
At 1, 3, 6 and 9 months and after one year
Study Arms (1)
Group 1
Interventions
Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.
Eligibility Criteria
Patients with diagnosis of advanced Renal Cell Carcimona
You may qualify if:
- Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 13, 2008
Study Start
June 1, 2008
Study Completion
November 1, 2010
Last Updated
June 15, 2012
Record last verified: 2012-06