Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer

NCT01353794 | Withdrawn

• 2 other identifiers: 15246NX0913IN
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Renal Cell

Keywords

SORAFENIB; RENAL CELL CARCINOMA; TYROSINE KINASE INHIBITOR; OBSERVATIONAL STUDY

Outcome Measures

Primary Outcomes (4)

• Efficacy related variables are status of tumor / metastases.

  After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)

• Efficacy related variables are patient's performance status.

  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.

  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

  After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)

Secondary Outcomes (1)

• General tolerability assessment by physician and reports of adverse events.

  After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of advanced RCC

You may qualify if:

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

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 16, 2011
• Study Start: December 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: April 1, 2018
• Last Updated: January 30, 2015

Record last verified: 2015-01