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Completed

NCT Number: NCT01508364

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Sorafenib (Nexavar, BAY 43-9006)

Drug

Dosage according to label or at discretion of the attending physician

Primary outcomes

  1. Duration of Nexavar treatment

    Time frame: up to 3 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 1 - 1.5 years after LPLV

  2. Health related quality of life (HRQoL)

    Time frame: up to 3 years

  3. Progression-free survival (PFS)

    Time frame: up to 3 years

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

    Time frame: up to 3 years

  5. Incidence of Treatment-emergent Adverse Events (TEAE)

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma

Acronym: NEXTAR

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2012
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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