N/A
Completed N=36
Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
Source: ClinicalTrials.gov NCT00836745 ↗Enrolled (actual)
36
Serious AEs
19.4%
Results posted
Dec 2013
Primary outcomePrimary: Progression Free Survival (PFS)
Summary
The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
— | — |
| SECONDARY Percentage of Participants With Objective Response (OR) |
— | — |
| SECONDARY Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events |
1; 1; 1 | — |
| SECONDARY Number of Participants Who Required Management of Other Adverse Events |
20 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with advanced renal cell cancer
- Treatment naïve or cytokine refractory
Exclusion Criteria
- Patients presenting with a known hypersensitivity to Sunitinib or its metabolites
Data sourced from ClinicalTrials.gov (NCT00836745). 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.