Clinical trial · Observational
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -
- 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 investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: 1. Confirmation of efficacy and safety for medical practice use. 2. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items). 3. Investigation of the incidence status and the risk factors for interstitial lung diseases.
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
- Temsirolimus
- description
- Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
- interventionNames
- Drug: Temsirolimus
Primary outcomes (2)
- measure
- Number of Participants With Adverse Drug Reactions
- timeFrame
- 96 weeks at maximum
- description
- An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening experience (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly. Relatedness to TORISEL Injection was assessed by the physician.
- measure
- Number of Participants With Adverse Drug Reactions of Major Investigation Items
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma). Exclusion Criteria: * Patients not administered Torisel. * Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.
References
Publications (1)
- DERIVEDSugiyama S, Sato K, Shibasaki Y, Endo Y, Uryu T, Toyoshima Y, Oya M, Miyanaga N, Saijo N, Gemma A, Akaza H. Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: recent consideration based on the results of a post-marketing, all-case surveillance study. Jpn J Clin Oncol. 2020 Aug 4;50(8):940-947. doi: 10.1093/jjco/hyaa062. PMID 32458996