Clinical trial · Observational
Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).
NCT00716625CI-TRIAL-00066121completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- sunitinib malate
- description
- Patients taking sunitinib malate
- interventionNames
- Drug: sunitinib malate
Primary outcomes (2)
- measure
- Number of Participants With Treatment-Related Adverse Events
- timeFrame
- MAX 2 Years
- description
- A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
- measure
- Objective Response Rate
- timeFrame
- MAX 2 Years
- description
- Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),\>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Days
Show eligibility criteria text
Inclusion Criteria: * Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance. Exclusion Criteria: * Patients not administered sunitinib malate (Sutent).
References
Publications (0)
Data not yet available
No reference posted for this study.