Metastatic Renal Cell CarcinomaPhase 3MRINCT00606866
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
A Phase 3 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
- At least one lesion that can be accurately measured in at least one dimension;
- Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
- Age 18 and older;
- ECOG performance status 0-2;
- Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
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- Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
- Any other investigational agents;
- Known brain metastases;
- Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- placebo, Sorafenib
- Keywords
- renal, metastatic, carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo for four weeks
SorafenibDrug
Sorafenib 200 mg twice daily
SorafenibDrug
Sorafenib, 400 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| I | Placebo comparator | placebo pill Receives: Drug: placebo |
| II | Active comparator | Sorafenib, 200 mg bid Receives: Drug: Sorafenib |
| III | Active comparator | Sorafenib, 400 mg bid Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib
Measured: 8 weeks
Secondary outcomes (1)
To predict which patients are most likely to experience tumor shrinkage.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJul 2004
- Primary completionJan 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606866
- Sponsor's protocol ID
- 12977A
- Acronym
- MRI
- Status last verified
- Nov 2023
- First submitted
- 31 Jan 2008
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00606866
- Acronym / sponsor ID
- MRI / 12977A
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal, metastatic, carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jul 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Feb 2008 (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 purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Placebo comparator | Drug: placeboplacebo pill |
| II | Active comparator | Drug: SorafenibSorafenib, 200 mg bid |
| III | Active comparator | Drug: SorafenibSorafenib, 400 mg bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
- At least one lesion that can be accurately measured in at least one dimension;
- Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
- Age 18 and older;
- ECOG performance status 0-2;
Key exclusion criteria (5 listed)
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
- Any other investigational agents;
- Known brain metastases;
- Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- Pregnancy.
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 |
|---|---|---|
| placeboPlacebo for four weeks | Drug | I |
| SorafenibSorafenib 200 mg twice daily | Drug | II |
| SorafenibSorafenib, 400 mg twice daily | Drug | III |
Primary outcome
To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib
Time frame: 8 weeks
1 secondary outcome
To predict which patients are most likely to experience tumor shrinkage.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by University of Chicago at 1 site in United States.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib (time frame: 8 weeks). 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 29 Nov 2023.