Phase 2
Completed N=61
SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00089648 ↗
Enrolled (actual)
61
Serious AEs
49.2%
Results posted
Dec 2009
Primary outcomePrimary: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) — 14 participants
Summary
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) |
14 | — |
| SECONDARY Time to Tumor Progression (TTP) |
30.4 | — |
| SECONDARY Duration of Response (DR) |
36.1 | — |
| SECONDARY Overall Survival (OS) |
47.1 | — |
| SECONDARY Progression Free Survival (PFS) |
30.4 | — |
| SECONDARY Trough Plasma Concentrations (Cmin) of Sunitinib |
52.05; 43.50; 46.10; 44.90 | — |
| SECONDARY Trough Plasma Concentrations (Cmin) of SU012662 |
30.50; 21.40; 22.10; 23.75 | — |
| SECONDARY Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662) |
85.40; 66.60; 68.40; 68.15 | — |
| SECONDARY Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A) |
567.4; 1320.6; 1212.3; 316.2 | — |
| SECONDARY Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) |
54170.4; 37747.0; 46891.0; 51280.0 | — |
| SECONDARY Plasma Concentration of Placental Growth Factor (PlGF) |
55.0; 146.1; 137.9 | — |
| SECONDARY Plasma Concentration of VEGF-C |
833.0; 688.0; 566.5 | — |
| SECONDARY Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease
- Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
- Prior radical or partial nephrectomy
Exclusion Criteria
- Prior treatment with any other anti-angiogenic therapy other than bevacizumab
- Prior systemic treatment for RCC > 2 regimens
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
Data sourced from ClinicalTrials.gov (NCT00089648). 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.