Phase 2
Completed N=106
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00077974 ↗
Enrolled (actual)
106
Serious AEs
43.4%
Results posted
Nov 2009
Primary outcomePrimary: Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) — 35 participants
Summary
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) |
35 | — |
| SECONDARY Time to Tumor Progression (TTP) |
46.3 | — |
| SECONDARY Duration of Response (DR) |
60.4 | — |
| SECONDARY Overall Survival (OS) |
104.1 | — |
| SECONDARY Progression-free Survival (PFS) |
38.0 | — |
| SECONDARY Percent Chance of Patient Survival |
67.2; 50.2 | — |
| SECONDARY Observed Plasma Trough Concentrations of Sunitinib |
46.82; 50.13; 49.36; 53.18; 1.55; 1.44 | — |
| SECONDARY Observed Plasma Trough Concentrations of Sunitinib Metabolite |
26.44; 28.21; 28.32; 28.54; 2.50; 2.64 | — |
| SECONDARY Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite |
73.26; 78.34; 77.68; 81.71; 4.04; 4.08 | — |
| SECONDARY Dose Corrected Plasma Trough Concentrations of Sunitinib |
53.64; 55.94; 69.44; 64.33; 1.94; 2.15 | — |
| SECONDARY Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite |
31.85; 28.15; 40.53; 38.04; 2.99; 3.35 | — |
| SECONDARY Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite |
85.49; 84.09; 109.97; 102.37; 4.93; 5.50 | — |
Eligibility Criteria
Inclusion Criteria
- Cytokine refractory metastatic renal cell carcinoma with clear cell component
- Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
- Prior nephrectomy
Exclusion Criteria
- Prior treatment with any systemic therapy other than 1 cytokine therapy
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
Data sourced from ClinicalTrials.gov (NCT00077974). 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.