Clinical trial · Observational
Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.
NCT00716820CI-TRIAL-00065404completedResults 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 |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
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 Sutent.
- 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 based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
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.