Carcinoma, Renal CellPhase 2NCT00338884
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
A Phase 2 study testing Sunitinib malate in people with Carcinoma, Renal Cell, run by Pfizer at 15 sites in 6 countries.
Trial summary
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sunitinib malate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Sep 2006to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Advanced kidney cancer
Who cannot join
- Previous treatment for kidney cancer, except surgical removal of kidney tumor
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, 1431
Pfizer Investigational Site
Córdoba, Córdoba Province, X5000AAI
Pfizer Investigational Site
Rosario, Santa Fe Province, (2000)
Australia3 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
East Bentleigh, Victoria, 3165
Taiwan3 sites
Pfizer Investigational Site
Taichung, 407
Pfizer Investigational Site
Tainan, 710
Pfizer Investigational Site
Taipei, 112
Brazil2 sites
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
São Paulo, São Paulo, 01308-050
Mexico2 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44280
Pfizer Investigational Site
Monterrey, Nuevo León, 64460
South Korea2 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
About this study
Official title: A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sunitinib malate
- 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.
Sunitinib malateDrug
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
| Study group | Role | What they receive |
|---|---|---|
| SUNITINIB MALATE. | Experimental | Sunitinib malate starting dose 37.5 mg daily continuous daily schedule Receives: Drug: Sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Overall Confirmed Objective Response (OR)
OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary outcomes (28)
Duration of Response (DR)
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.
Measured: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
Time to Tumor Progression (TTP)
Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.
Measured: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Progression-Free Survival (PFS)
Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.
Measured: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
1-Year Survival
One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
Measured: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the concentration prior to study drug administration.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Correlated With Serious Adverse Events (SAEs)
Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Measured: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
Measured: Baseline
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
Measured: Baseline (Cycle 1, Day 1)
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
Measured: Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
Measured: Baseline to Day 1 of Weeks 3 through 53
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
Measured: Baseline to Day 1 of Weeks 3 through 53
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).
Measured: Baseline to Day 1 of Weeks 3 through 53
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Measured: Baseline
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
Measured: Baseline (Cycle 1, Day 1)
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
Measured: Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Measured: Baseline to Day 1 of Weeks 3 through 53
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
Measured: Baseline to Day 1 of Weeks 3 through 53
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).
Measured: Baseline to Day 1 of Weeks 3 through 53
Patient-Assessed Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.
Measured: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Cancer Related Symptoms, Well-Being, and Concerns
FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.
Measured: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338884
- Sponsor's protocol ID
- A6181110
- Status last verified
- Aug 2012
- First submitted
- 16 Jun 2006
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
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 25577718Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.
PubMed 21898376
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00338884
- Acronym / sponsor ID
- A6181110
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Posted 14 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUNITINIB MALATE. | Experimental | Drug: Sunitinib malateSunitinib malate starting dose 37.5 mg daily continuous daily schedule |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced kidney cancer
Key exclusion criteria (1 listed)
- Previous treatment for kidney cancer, except surgical removal of kidney tumor
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 |
|---|---|---|
| Sunitinib malateSunitinib malate starting dose 37.5 mg daily continuous daily schedule | Drug | SUNITINIB MALATE. |
Primary outcome
Number of Subjects With Overall Confirmed Objective Response (OR)
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
28 secondary outcomes
Duration of Response (DR)
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
Time to Tumor Progression (TTP)
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Progression-Free Survival (PFS)
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
1-Year Survival
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
Trough Plasma Concentrations (Ctrough) of Sunitinib
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough of SU-012662 (Sunitinib's Metabolite)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough of Total Drug (Sunitinib + SU-012662)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Correlated With Serious Adverse Events (SAEs)
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
Time frame: Baseline
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Time frame: Baseline (Cycle 1, Day 1)
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Time frame: Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
Time frame: Baseline to Day 1 of Weeks 3 through 53
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Time frame: Baseline to Day 1 of Weeks 3 through 53
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Time frame: Baseline to Day 1 of Weeks 3 through 53
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Time frame: Baseline
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Time frame: Baseline (Cycle 1, Day 1)
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Time frame: Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
Time frame: Baseline to Day 1 of Weeks 3 through 53
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Time frame: Baseline to Day 1 of Weeks 3 through 53
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Time frame: Baseline to Day 1 of Weeks 3 through 53
Patient-Assessed Fatigue
Time frame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Cancer Related Symptoms, Well-Being, and Concerns
Time frame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 21898376Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib malate in people with Carcinoma, Renal Cell, run by Pfizer at 15 sites in 6 countries.
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: finished, as of the sponsor's last update on 31 Aug 2012. 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 Argentina, Australia, Taiwan, Brazil, Mexico and 1 more country. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Overall Confirmed Objective Response (OR) (time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter). 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 NCT00338884, which also lists 4 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 31 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.