Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Other: No intervention

• Registration Number: NCT01585974
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-10
• Primary Completion: 2015-06
• Study Completion: 2015-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• To be diagnosed as metastatic renal cell carcinoma
• Previous cytokine therapy
• To sign informed consent form (ICF)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	No intervention	-

Primary Outcome Measures

Name	Time	Method
Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product	After 2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAE)	After 2 years
Change of Tumor status	Baseline and 2 years