N/A
Completed N=186
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Source: ClinicalTrials.gov NCT00684645 ↗Enrolled (actual)
186
Serious AEs
16.7%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants With Objective Response — 25.3 percentage of participants
Summary
Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response |
25.3 | — |
| PRIMARY Progression-free Survival (PFS) |
9.8 | — |
| PRIMARY Overall Survival (OS) |
NA | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6 |
18.8; 68.3; 8.6; 2.2; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3 |
16.7; 60.2; 10.2; 2.7; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6 |
14.5; 47.8; 4.3; 1.6; 1.1; 0.0 | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9 |
11.8; 36.6; 4.8; 0.5; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12 |
15.1; 39.8; 8.1; 4.8; 0.5; 1.1 | — |
| PRIMARY Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS) |
39; 16; 11; 12; 4 | <0.0001 sig |
| PRIMARY Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS) |
39; 16; 11; 12; 4 | 0.0221 sig |
| PRIMARY Percentage of Participants With Hypothyroidism |
8.1; 17.9; 18.3; 20.0; 20.9 | — |
| PRIMARY Percentage of Participants With Hypertension |
64.0; 51.1; 48.8; 54.2; 54.0; 39.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with advanced or metastatic renal cell carcinoma.
Exclusion Criteria
- No previous cytokines therapy.
Data sourced from ClinicalTrials.gov (NCT00684645). 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.