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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01353794
First received: May 13, 2011
Last updated: July 1, 2014
Last verified: June 2014

May 13, 2011
July 1, 2014
June 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]
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.
 
Not yet recruiting
200
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.
Both
Not Provided
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
India
 
NCT01353794
15246, NX0913IN
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP