Nexavar as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma

NCT01508364 | Completed

• 2 other identifiers: 16091NX1111
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.

Conditions

Carcinoma, Renal Cell

Keywords

renal cell carcinoma, first targeted therapy, observational study

Outcome Measures

Primary Outcomes (1)

• Duration of Nexavar treatment

  up to 3 years

Secondary Outcomes (5)

• Overall Survival (OS)

  1 - 1.5 years after LPLV

• Health related quality of life (HRQoL)

  up to 3 years

• Progression-free survival (PFS)

  up to 3 years

• Tumor status, of patients will be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression".

  up to 3 years

• Incidence of Treatment-emergent Adverse Events (TEAE)

  up to 3 years

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY 43-9006)

Interventions

Sorafenib (Nexavar, BAY 43-9006) DRUG

Dosage according to label or at 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: Non-Probability Sample

Study Population

The study population will consist of patients with metastatic/advanced RCC (all histologies), who failed prior cytokine therapy or are not suitable for cytokine therapy and for whom Nexavar constitutes first targeted therapy.

You may qualify if:

• Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
• Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.

You may not qualify if:

• Prior targeted therapy for RCC
• Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

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: January 3, 2012
• First Posted: January 12, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

DE (1)