Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT ID: NCT01210482
Last Updated: 2024-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
1050 participants
OBSERVATIONAL
2010-08-24
2018-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Temsirolimus
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
Temsirolimus
The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via gradual intravenous infusion over 30\~60 minutes. The dosage is to be appropriately reduced according to patients' status.
Interventions
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Temsirolimus
The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via gradual intravenous infusion over 30\~60 minutes. The dosage is to be appropriately reduced according to patients' status.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.
15 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Kyusyu University Hospital
Fukuoka, Fukuoka PREF, Japan
Countries
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References
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Sugiyama 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1771015
Identifier Type: OTHER
Identifier Source: secondary_id
3066K5-4406
Identifier Type: -
Identifier Source: org_study_id
NCT01420601
Identifier Type: -
Identifier Source: nct_alias
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