MedDataX Logo

Sorafenib in Elderly mRCC

NCT ID: NCT01728948

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-06

Study Completion Date

2017-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Renal Cell

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Sorafenib renal cell carcinoma(RCC) elderly effectiveness safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

treatment (including dose, duration, modification) decided by the investigator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sorafenib (Nexavar, BAY43-9006)

treatment (including dose, duration, modification) decided by the investigator

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
* \>=65 years of age
* Patients who have signed the informed consent
* Patients with a life expectancy of ≥12 weeks
* No prior systemic treatment
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Many Locations, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NX1212CN

Identifier Type: OTHER

Identifier Source: secondary_id

16399

Identifier Type: -

Identifier Source: org_study_id