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Sorafenib in Elderly mRCC

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ClinicalTrials.gov Identifier: NCT01728948
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

Condition or disease Intervention/treatment
Carcinoma, Renal Cell Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib
Actual Study Start Date : January 6, 2013
Actual Primary Completion Date : January 4, 2016
Actual Study Completion Date : January 16, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
treatment (including dose, duration, modification) decided by the investigator




Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 2.5 years ]

Secondary Outcome Measures :
  1. Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria [ Time Frame: up to 2.5 years ]
  2. Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria [ Time Frame: up to 2.5 years ]
  3. Survival rate by one year [ Time Frame: up to 1 year ]
  4. Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability [ Time Frame: up to 3.5 years ]
  5. Patient characteristics (birthdate (at least year), sex, weight, height, etc) [ Time Frame: up to 2.5 years ]
  6. Response rate (RR) [ Time Frame: up to 3.5 years ]
  7. Time to first relief of clinical symptoms and physical signs [ Time Frame: up to 3.5 years ]
  8. Treatment pattern [ Time Frame: up to 3.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mRCC patients, >= 65 years of age, No prior systemic treatment, need systemic therapy
Criteria

Inclusion Criteria:

  • Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
  • >=65 years of age
  • Patients who have signed the informed consent
  • Patients with a life expectancy of ≥12 weeks
  • No prior systemic treatment

Exclusion Criteria:

  • The approved local product label must be followed for the exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728948


Locations
China
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01728948     History of Changes
Other Study ID Numbers: 16399
NX1212CN ( Other Identifier: company internal )
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Bayer:
Sorafenib
renal cell carcinoma(RCC)
elderly
effectiveness
safety

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs