Phase 3
Completed N=750
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00083889 ↗
Enrolled (actual)
750
Serious AEs
35.8%
Results posted
Dec 2009
Primary outcomePrimary: Progression-Free Survival (PFS), Core Radiology Assessment — 48.3; 22.1 weeks — p=<0.0001
Summary
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS), Core Radiology Assessment |
48.3; 22.1 | <0.0001 sig |
| PRIMARY Progression-Free Survival (PFS), Investigator's Assessment |
47.7; 22.1 | <0.0001 sig |
| SECONDARY Objective Response, Core Radiology Assessment |
145; 29 | <0.001 sig |
| SECONDARY Objective Response, Investigator's Assessment |
171; 45 | <0.001 sig |
| SECONDARY Overall Survival (OS) |
114.6; 94.9 | 0.0510 |
| SECONDARY Time to Tumor Progression (TTP), Core Radiology Assessment |
49.1; 22.4 | <0.0001 sig |
| SECONDARY Time to Tumor Progression (TTP), Investigator's Assessment |
49.0; 22.3 | <0.0001 sig |
| SECONDARY Duration of Response (DR), Core Radiology Assessement |
52.9; 64.9 | — |
| SECONDARY Duration of Response (DR), Investigator's Assessment |
56.3; 48.1 | — |
| SECONDARY FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale |
29.74; 29.55; 27.73; 26.68; 29.66; 27.59 | <.0001 sig |
| SECONDARY FACT-Kidney Symptom Index (FKSI) Subscale |
46.45; 46.09; 42.71; 40.93; 45.98; 42.33 | <.0001 sig |
| SECONDARY Functional Assessment of Cancer Therapy-General (FACT-G) |
82.30; 81.22; 78.75; 74.91; 82.88; 77.02 | <.0001 sig |
| SECONDARY Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale |
23.14; 22.70; 19.43; 18.85; 22.22; 20.05 | <.0001 sig |
| SECONDARY Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale |
23.14; 22.94; 23.60; 22.20; 23.50; 22.31 | <.0001 sig |
| SECONDARY Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale |
17.15; 17.06; 17.76; 17.40; 18.46; 17.52 | 0.0001 sig |
| SECONDARY Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale |
18.93; 18.51; 17.92; 16.37; 18.78; 17.08 | <.0001 sig |
| SECONDARY EuroQoL Five Dimension (EQ-5D) Health State Index |
0.76; 0.76; 0.72; 0.70; 0.78; 0.75 | 0.0004 sig |
| SECONDARY Euro-QoL Visual Analog Scale (EQ-VAS) |
73.80; 71.43; 69.35; 67.66; 75.05; 70.45 | <.0001 sig |
| SECONDARY Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis |
101.9; 109.0; 4.280; 1.134; 1.161; 1.171 | — |
| SECONDARY Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis |
0.760; 1.582; 1.671; 2.895; 0.803 | — |
| SECONDARY Incremental Cost Effectiveness Ratio (ICER) |
0; 0 | — |
| SECONDARY Ctrough Concentrations of SU011248 |
57.26; 57.59; 50.26; 45.05; 64.22; 59.90 | — |
| SECONDARY Ctrough Concentrations of Metabolite SU012662 |
27.10; 27.35; 26.11; 22.11; 28.21; 28.32 | — |
| SECONDARY Ctrough Concentrations of SU011248 and Active Metabolite SU012662 |
84.36; 84.94; 76.37; 67.15; 92.43; 88.22 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease by radiographic technique
- Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1
Exclusion Criteria
- Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
Data sourced from ClinicalTrials.gov (NCT00083889). 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.