stop_circleTerminated/Withdrawn
Carcinoma, Renal Cell
Bayer Identifier:
15246
ClinicalTrials.gov Identifier:
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
BothAge
NaN - N/ATrial summary
Enrollment Goal
0Trial Dates
December 2014 - April 2018Phase
Phase 4Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Many Locations, India |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_encryptionNoSafety Issue:
- 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_encryptionNoSafety Issue:
- 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_encryptionNoSafety Issue:
- Efficacy related variable - Quality of Life (QOL) assessment by the patientdate_rangeTime Frame:After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)enhanced_encryptionNoSafety Issue:
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_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
Non-randomizedBlinding
N/AAssignment
N/ATrial Arms
N/A