Carcinoma, Renal CellPOWER-NEXTNCT01353794
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer
An observational study of Carcinoma, Renal Cell, run by Bayer.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of advanced RCC
Who may be able to join
- Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information.
About this study
Official title: Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
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.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- SORAFENIB, RENAL CELL CARCINOMA, TYROSINE KINASE INHIBITOR, OBSERVATIONAL STUDY
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy related variables are status of tumor / metastases.
Measured: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variables are patient's performance status.
Measured: 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.
Measured: 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
Measured: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Secondary outcomes (1)
General tolerability assessment by physician and reports of adverse events.
Measured: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startDec 2014
- Primary completionSep 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353794
- Sponsor's protocol ID
- 15246
- Other IDs
- NX0913IN
- Acronym
- POWER-NEXT
- Status last verified
- Jan 2015
- First submitted
- 13 May 2011
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01353794
- Acronym / sponsor ID
- POWER-NEXT / 15246
- Conditions
- Carcinoma, Renal Cell
- Keywords
- SORAFENIB, RENAL CELL CARCINOMA, TYROSINE KINASE INHIBITOR, OBSERVATIONAL STUDY
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Sorafenib (Nexavar, BAY43-9006) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of advanced RCC
Key inclusion criteria (1 listed)
- Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Group 1 |
Primary outcome
Efficacy related variables are status of tumor / metastases.
Time frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variables are patient's performance status.
Time frame: 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.
Time frame: 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
Time frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
1 secondary outcome
General tolerability assessment by physician and reports of adverse events.
Time frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy related variables are status of tumor / metastases. (time frame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.