Phase 2
Completed N=120
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00338884 ↗
Enrolled (actual)
120
Serious AEs
37.8%
Results posted
Jun 2011
Primary outcomePrimary: Number of Subjects With Overall Confirmed Objective Response (OR) — 41 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Overall Confirmed Objective Response (OR) |
41 | — |
| SECONDARY Duration of Response (DR) |
7.14 | — |
| SECONDARY Time to Tumor Progression (TTP) |
10.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
9.0 | — |
| SECONDARY 1-Year Survival |
67.8 | — |
| SECONDARY Trough Plasma Concentrations (Ctrough) of Sunitinib |
7.15; 54.78; 45.64; 46.35; 47.54; 41.29 | — |
| SECONDARY Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib |
0.000; 57.900; 45.000; 45.400; 46.250; 40.000 | 0.5581 |
| SECONDARY Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib |
0.000; 55.300; 44.600; 46.750; 49.500; 39.550 | 0.7154 |
| SECONDARY Ctrough of SU-012662 (Sunitinib's Metabolite) |
2.62; 20.27; 20.25; 20.41; 21.18; 20.01 | — |
| SECONDARY Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) |
0.000; 18.250; 16.650; 17.300; 15.100; 15.900 | 0.5784 |
| SECONDARY Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) |
0.000; 18.800; 17.300; 17.900; 18.700; 16.350 | 0.7267 |
| SECONDARY Ctrough of Total Drug (Sunitinib + SU-012662) |
9.77; 75.04; 65.89; 66.76; 68.72; 61.31 | — |
| SECONDARY Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) |
0.000; 76.950; 65.900; 66.100; 65.150; 57.600 | 0.5784 |
| SECONDARY Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) |
0.000; 75.000; 63.300; 66.400; 70.600; 57.600 | 0.7267 |
| SECONDARY Ctrough Correlated With Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline |
154.8 | — |
| SECONDARY VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) |
73.600; 109.300 | 0.0680 |
| SECONDARY VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) |
86.400; 109.300 | 0.1159 |
| SECONDARY VEGF Ratio to Baseline at Each Time Point |
2.9; 2.6; 2.6; 3.4; 3.2; 2.8 | — |
| SECONDARY VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) |
1.999; 1.948; 1.383; 2.471; 1.761; 1.405 | 0.8519 |
| SECONDARY VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) |
2.127; 1.948; 1.574; 2.471; 1.798; 1.405 | 0.6939 |
| SECONDARY Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline |
9163.4 | — |
| SECONDARY sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) |
9968.000; 8342.750 | 0.0292 sig |
| SECONDARY sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) |
9772.500; 8342.750 | 0.1087 |
| SECONDARY sVEGFR2 Ratio to Baseline at Each Time Point |
0.7; 0.6; 0.6; 0.6; 0.6; 0.6 | — |
| SECONDARY sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) |
0.704; 0.653; 0.638; 0.531; 0.596; 0.574 | 0.3386 |
| SECONDARY sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) |
0.691; 0.653; 0.625; 0.531; 0.599; 0.574 | 0.4632 |
| SECONDARY Patient-Assessed Fatigue |
39.29; 36.98; 35.44; 36.54; 36.82; 35.94 | — |
| SECONDARY Cancer Related Symptoms, Well-Being, and Concerns |
44.68; 43.69; 42.71; 43.69; 44.11; 43.26 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced kidney cancer
Exclusion Criteria
- Previous treatment for kidney cancer, except surgical removal of kidney tumor
Data sourced from ClinicalTrials.gov (NCT00338884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.