Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® (PONDIAC)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00771147
First received: October 9, 2008
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.


Condition Intervention
Carcinoma, Renal Cell
Carcinoma, Renal Cell (Advanced)
Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: At 1, 3, 6 and 9 months and after one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 71
Study Start Date: June 2008
Study Completion Date: November 2010
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diagnosis of advanced Renal Cell Carcimona

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the Belgian product information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771147

Locations
Belgium
Many Locations, Belgium
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00771147     History of Changes
Other Study ID Numbers: 13102, NX0710BE
Study First Received: October 9, 2008
Last Updated: June 14, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Bayer:
Advanced Renal Cell Carcinoma ( RCC)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014