Clinical trial · Observational
A Post Marketing Surveillance As Required By Philippine Food And Drug Administration
An Open Label, Non-interventional Study Of The Safety Of Temsirolimus Injection (Torisel) In The Treatment Of Advanced Renal Cell Carcinoma In Filipino Adult Patients: A Post Marketing Surveillance Study
NCT01781442CI-TRIAL-00010175withdrawnClinicalTrials.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)
This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patient Arm- temsirolimus
- interventionNames
- Drug: Temsirolimus
Primary outcomes (1)
- measure
- Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects that will be included in this post marketing surveillance study must be consistent with the approved label indication of Torisel in the Philippines. * As per approved label indication, patients diagnosed with advanced renal cell carcinoma will be the ones eligible to participate in the study. * The decision to prescribe Torisel will necessarily precede and will be independent of the decision to enroll the patient into the study. * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: * Subjects with conditions that are contraindicated with Torisel based on the approved local product document in the Philippines will be excluded in this study. This condition includes: Patients with bilirubin \>1.5 x ULN.
References
Publications (0)
Data not yet available
No reference posted for this study.