stop_circleTerminated/Withdrawn

Carcinoma, Renal Cell

Bayer Identifier:

15246

ClinicalTrials.gov Identifier:

NCT01353794

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to observe safety and efficacy of Nexavar in treatment of kidney cancer

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

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

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

Trial summary

Enrollment Goal
0
Trial Dates
December 2014 - April 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many Locations, India

Primary Outcome

  • Efficacy related variables are status of tumor / metastases.
    date_rangeTime Frame:
    After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy related variables are patient's performance status.
    date_rangeTime Frame:
    After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy related variables are efficacy assessment by the physician.
    date_rangeTime Frame:
    After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy related variable - Quality of Life (QOL) assessment by the patient
    date_rangeTime Frame:
    After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • General tolerability assessment by physician and reports of adverse events.
    date_rangeTime Frame:
    After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
Non-randomized
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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