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

Carcinoma, Renal Cell Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01353794
• Other study ID #: 15246
• Secondary ID: NX0913IN
• Status: Withdrawn
• Phase: Phase 4
• First received: May 13, 2011
• Last updated: January 29, 2015
• Start date: December 2014
• Est. completion date: April 2018

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria must be read in conjunction with the local product information.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy related variables are status of tumor / metastases.		After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)	No
Primary	Efficacy related variables are patient's performance status.		After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	Yes

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