Metastatic Renal Cell CarcinomaNCT00531544
A SU011248 Expanded Access Protocol for Systemic Therapy of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
A study testing SU011248 in people with Metastatic Renal Cell Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- SU011248
- How many people
- 350 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2007to Jun 2012
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SU011248 Expanded Access Protocol for Metastatic RCC Patients Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- SU011248
- 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.
SU011248Drug
SU011248 Expanded Access Protocol for Systemic Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 2001-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2012
- Study completionJun 2012
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shouki Bazarbashi, MD, Principal investigator, KFSH&RC, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531544
- Sponsor's protocol ID
- RAC#2061 043
- Status last verified
- Jan 2016
- First submitted
- 17 Sep 2007
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SU011248 Expanded Access Protocol for Metastatic RCC Patients Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
- ClinicalTrials.gov ID
- NCT00531544
- Acronym / sponsor ID
- RAC#2061 043
- Conditions
- Metastatic Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Sep 2007 (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.
A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SU011248SU011248 Expanded Access Protocol for Systemic Therapy | Drug | – |
Primary outcome
Efficacy
Time frame: 2001-2012
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 5 Jan 2016.
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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.
Shouki Bazarbashi, MD principal investigator
KFSH&RC, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SU011248 in people with Metastatic Renal Cell Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 0 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 5 Jan 2016. 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 Saudi Arabia. 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. 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 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?
Efficacy (time frame: 2001-2012). 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 5 Jan 2016.