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Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer (POWER-NEXT)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353794
First Posted: May 16, 2011
Last Update Posted: January 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
May 13, 2011
May 16, 2011
January 30, 2015
December 2014
September 2017   (Final data collection date for primary outcome measure)
  • Efficacy related variables are status of tumor / metastases. [ Time Frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) ]
  • Efficacy related variables are patient's performance status. [ Time Frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) ]
  • Efficacy related variables are efficacy assessment by the physician. [ Time Frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) ]
  • Efficacy related variable - Quality of Life (QOL) assessment by the patient [ Time Frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) ]
Same as current
Complete list of historical versions of study NCT01353794 on ClinicalTrials.gov Archive Site
General tolerability assessment by physician and reports of adverse events. [ Time Frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) ]
Same as current
Not Provided
Not Provided
 
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer
Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients of advanced RCC
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)
The treatment with Sorafenib 200mg tablets should comply with the recommendations written in the local product information. The decision about the duration of treatment is solely at the discretion of the attending physician
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2018
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
India
 
NCT01353794
15246
NX0913IN ( Other Identifier: Company Internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2015