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

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ClinicalTrials.gov Identifier: NCT01353794
Recruitment Status : Withdrawn
First Posted : May 16, 2011
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

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

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
Study Start Date : December 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 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



Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of advanced RCC
Criteria

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.

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): NCT01353794


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01353794     History of Changes
Other Study ID Numbers: 15246
NX0913IN ( Other Identifier: Company Internal )
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Bayer:
SORAFENIB
RENAL CELL CARCINOMA
TYROSINE KINASE INHIBITOR
OBSERVATIONAL STUDY

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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action