Phase 2
Completed N=51
Study of SU011248 in Patients With Advanced Kidney Cancer
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00254540 ↗
Enrolled (actual)
51
Serious AEs
54.9%
Results posted
Feb 2010
Primary outcomePrimary: Number of Subjects With Objective Response — 12; 12; 1; 0 participants
Summary
To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Objective Response |
12; 12; 1; 0; 11; 12 | — |
| SECONDARY Progression-Free Survival (PFS) |
53.0; 46.0 | — |
| SECONDARY Time To Tumor Progression (TTP) |
53.0; 46.0 | — |
| SECONDARY Duration of Response (DR) |
111.6; 38.1 | — |
| SECONDARY Time to Tumor Response (TTR) |
10.0; 10.5 | — |
| SECONDARY Overall Survival Time |
143.4; 141.0 | — |
| SECONDARY Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score |
-0.0937; -0.0604; -0.0067; 0.0513; -0.0946; -0.0957 | — |
| SECONDARY Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS) |
-11.12; -10.54; -2.10; 4.17; -7.85; -11.82 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population |
81.60; 71.00; 1.24; 61.45; 71.30 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population |
85.90; 75.00; 57.70 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population |
36.10; 50.50; 2.14; 35.15; 33.55 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population |
31.60; 25.70; 17.50 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population |
130.30; 137.20; 3.67; 93.95; 114.70 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population |
115.10; 100.70; 75.20 | — |
| SECONDARY Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) |
54.90; 186.60; 259.90; 57.35; 264.75; 194.15 | — |
| SECONDARY Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) |
9311.00; 4673.50; 3650.00; 7276.50; 3535.00; 3312.50 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven renal cell carcinoma with metastases with a component of clear cell histology
Exclusion Criteria
- Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.
Data sourced from ClinicalTrials.gov (NCT00254540). 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.