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 August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01353794
First received: May 13, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: December 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353794

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
India
Not yet recruiting
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01353794     History of Changes
Other Study ID Numbers: 15246, NX0913IN
Study First Received: May 13, 2011
Last Updated: August 26, 2014
Health Authority: India: Drugs Controller General of India

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014