A Phase 2 interventional study of SU011248 (sunitinib) in Carcinoma, Renal Cell Metastasis, sponsored by Pfizer. Completed at 10 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-30.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 107 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single-arm study
Drug: SU011248 (sunitinib)
37.5 mg/day, oral, continuous daily dosing
Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Duration of Tumor Response
Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Time to Tumor Progression (TTP)
Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Progression Free Survival (PFS)
Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Overall Survival
Overall survival is time from the date of first dose of medication to the date of death due to any cause
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Summary of FACIT Fatigue Scale Overall Score
FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.
Time frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index
EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.
Time frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score
EQ-VAS score on the self-rated "thermometer" indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).
Time frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
Patients must have failed 1 prior cytokine-based therapy for metastatic renal cell carcinoma and had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
| Milestone | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Started | 54 | 53 |
| Completed | 15 | 9 |
| Not completed | 39 | 44 |
| Withdrew: Adverse event | 7 | 9 |
| Withdrew: Consent withdrawn | 1 | 1 |
| Withdrew: Lack of efficacy | 31 | 33 |
| Withdrew: Death | 0 | 1 |
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
| participants | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects | 15 | 6 |
Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.
| weeks | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Duration of Tumor Response | 24.0 (16.1 to 64.1) | 32.0 (16.1 to 32.1) |
Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).
| weeks | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Time to Tumor Progression (TTP) | 35.7 (27.9 to 50.0) | 35.9 (20.3 to 38.1) |
Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).
| weeks | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Progression Free Survival (PFS) | 35.7 (27.6 to 50.0) | 35.3 (20.3 to 38.1) |
Overall survival is time from the date of first dose of medication to the date of death due to any cause
| weeks | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Overall Survival | 91.4 (69.4 to 115.4) | 76.4 (59.6 to 108.3) |
FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.
| score on scale | AM Dose Sunitinib Malate | PM Dose Sunitinib Malate |
|---|---|---|
| Baseline Score n=52,52 | 39.5 ± 11.41 | 39.6 ± 10.15 |
| Maximum Post-Baseline Score n=53,52 | 43.4 ± 7.86 | 42.7 ± 8.19 |
| Minimum Post-Baseline Score n=53,52 | 28.0 ± 12.34 | 29.4 ± 13.65 |
EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.
| score on scale | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Maximum Increase | 0.0 (-0.7 to 0.9) | 0.0 (-0.3 to 1.0) |
| Maximum Decrease | 0.0 (-0.8 to 0.8) | -0.1 (-0.6 to 0.7) |
EQ-VAS score on the self-rated "thermometer" indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).
| score on scale | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Maximum Increase | 0.0 (-40.0 to 32.0) | 0.0 (-45.0 to 92.0) |
| Maximum Decrease | -10.0 (-51.0 to 80.0) | -9.0 (-40.0 to 44.0) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AM Dose Sunitinib Malate (SU011248) | — | — | — |
| PM Dose Sunitinib Malate (SU011248) | — | — | — |
| Event | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| Abdominal painGastrointestinal disorders | 4/54 | 3/53 |
| Disease progressionGeneral disorders | 0/54 | 3/53 |
| AnorexiaMetabolism and nutrition disorders | 1/54 | 3/53 |
| DehydrationMetabolism and nutrition disorders | 1/54 | 3/53 |
| ThrombocytopeniaBlood and lymphatic system disorders | 3/54 | 1/53 |
| AnaemiaBlood and lymphatic system disorders | 1/54 | 2/53 |
| HaematemesisGastrointestinal disorders | 1/54 | 2/53 |
| NauseaGastrointestinal disorders | 0/54 | 2/53 |
| AstheniaGeneral disorders | 1/54 | 2/53 |
| FatigueGeneral disorders | 0/54 | 2/53 |
| Event | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 41/54 | 40/53 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 28/54 | 23/53 |
| StomatitisGastrointestinal disorders | 25/54 | 21/53 |
| NauseaGastrointestinal disorders | 25/54 | 19/53 |
| HypertensionVascular disorders | 25/54 | 23/53 |
| AstheniaGeneral disorders | 24/54 | 20/53 |
| FatigueGeneral disorders | 19/54 | 22/53 |
| DyspepsiaGastrointestinal disorders | 22/54 | 15/53 |
| AnorexiaMetabolism and nutrition disorders | 21/54 | 20/53 |
| Hair colour changesSkin and subcutaneous tissue disorders | 18/54 | 20/53 |
| Age Continuous(years) | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) | Total |
|---|---|---|---|
| Mean | 59.3 ± 9.27 | 57.2 ± 11.48 | 58.2 ± 10.43 |
| Sex: Female, Male(Participants) | AM Dose Sunitinib Malate (SU011248) | PM Dose Sunitinib Malate (SU011248) | Total |
|---|---|---|---|
| Female | 8 | 11 | 19 |
| Male | 46 | 42 | 88 |
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