Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy

NCT01195649 | Terminated

• 2 other identifiers: 15242NX1010TW
• Study Type: observational
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this prospective, observational, post-marketing study is to evaluate the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with Nexavar® has been made under real-life practice settings and approved reimbursement restriction in Taiwan. Therefore, the main objective of the study is to collect data on: Prescription pattern: to determine the factors affecting compliance and duration of treatment with special attention given to education status, demography, disease details, pre-treatment, concomitant medication and other baseline data Nexavar® treatment and efficacy data Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (2)

• Evaluation of Safety and Efficacy of treatments and average doses that are used for patients with Renal Cell Carcinoma (collection of number of adverse events)

  After one year

• Evaluation of Safety and Efficacy of treatments and average doses that are used for patients with Renal Cell Carcinoma (collection of changes in tumor status)

  After one year

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Patients under daily life treatment according to local drug information

Group 1

Eligibility Criteria

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

Study Population

Taiwanese patients

You may qualify if:

• Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Nexavar® under Taiwan reimbursement guideline
• Patients must have a life expectancy of at least 8 weeks

You may not qualify if:

• Patients were lost to follow-up if no follow-up visit and no final assessment of Nexavar® was documented.

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: August 12, 2010
• First Posted: September 6, 2010
• Study Start: December 13, 2010
• Primary Completion: June 8, 2012
• Study Completion: August 31, 2012
• Last Updated: June 4, 2019

Record last verified: 2019-06