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

Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01353794

Acronym

POWER-NEXT

Enrollment

Registered

2011-05-16

Start date

2014-12-31

Completion date

2018-04-30

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

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

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.

Interventions

DRUGSorafenib (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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026