Kidney NeoplasmsPhase 2NCT00054886
Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
A Phase 2 study testing SU-011,248 in people with Kidney Neoplasms, run by Pfizer at 15 sites in United States.
Trial summary
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- SU-011,248
- How many people
- 63 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2003to Aug 2004
- Phase
- Phase 2
- 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
- Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
- The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
- Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function
Who cannot join
- Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
- Prior surgical resection of or irradiation to the only site of measurable disease;
- Ongoing severe hematuria;
- Other active second malignancy;
- Cardiovascular diseases or conditions within the last 12 months;
- Known brain metastases;
Show all 10Show fewer
- Known HIV-positive or AIDS-related illness;
- Pregnant or breast-feeding women;
- Current participation in other clinical trials;
- Other severe acute or chronic medical conditions.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Henderson, Nevada, 89052
Pfizer Investigational Site
Las Vegas, Nevada, 89109
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Mission Hills, California, 91345
Pfizer Investigational Site
Monterey Park, California, 91754
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Northridge, California, 91328
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94121
About this study
Official title: Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.
- Conditions
- Kidney Neoplasms
- Being tested
- SU-011,248
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU-011,248Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Secondary outcomes (1)
The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2003 (estimated)
- Study startJan 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054886
- Sponsor's protocol ID
- RTKC-0511-014
- Status last verified
- Jul 2006
- First submitted
- 12 Feb 2003
- Last updated
- 7 May 2007
- Results posted
- No
Publications
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
PubMed 28410911Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
PubMed 27238653Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
PubMed 25577718
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00054886
- Acronym / sponsor ID
- RTKC-0511-014
- Conditions
- Kidney Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Aug 2004 (actual)
- First posted
- 13 Feb 2003 (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 primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
- The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
- Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function
Key exclusion criteria (10 listed)
- Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
- Prior surgical resection of or irradiation to the only site of measurable disease;
- Ongoing severe hematuria;
- Other active second malignancy;
- Cardiovascular diseases or conditions within the last 12 months;
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 |
|---|---|---|
| SU-011,248 | Drug | – |
Primary outcome
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
1 secondary outcome
The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
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 7 May 2007.
- Derived from this study: PubMed 28410911de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Derived from this study: PubMed 27238653Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Derived from this study: PubMed 25577718Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Kidney Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SU-011,248 in people with Kidney Neoplasms, run by Pfizer at 15 sites 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 3 inclusion and 10 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 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00054886, which also lists 3 linked publications.
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 7 May 2007.