check_circleStudy Completed

Renal Cell Carcinoma

Bayer Identifier:

16263

ClinicalTrials.gov Identifier:

NCT01585974

EudraCT Number:

Not Available

EU CT Number:

Not Available
Duration of treatment with tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma

Trial purpose

This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - To be diagnosed as metastatic renal cell carcinoma
    - Previous cytokine therapy
    - To sign informed consent form (ICF)


  • - Patients not willing to sign informed consent form or who withdraw their consent

Trial summary

Enrollment Goal
151
Trial Dates
October 2012 - November 2015
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Turkey

Primary Outcome

  • Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product
    date_rangeTime Frame:
    After 2 years
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    Safety Issue:
    No

Secondary Outcome

  • Incidence of treatment-emergent adverse events (TEAE)
    date_rangeTime Frame:
    After 2 years
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    Safety Issue:
    Yes
  • Change of Tumor status
    date_rangeTime Frame:
    Baseline and 2 years
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    Safety Issue:
    No

Trial design

Duration of treatment with TKIs in the treatment of Metastatic Renal Cell Carcinoma
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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