Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01210482
ABOUT THIS STUDY
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- Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
- Patients not administered Torisel.
- Patients with a history of severe hypersensitivity to temsirolimus, sirolimus
derivative, or any of their components and/or derivatives.
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Descriptive Information | ||||
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Brief Title | Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) | |||
Official Title | Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel | |||
Brief Summary | The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:
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Detailed Description | Implemented as a Drug Use Investigation by Central Registration System | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma). | |||
Condition | Renal Cell Carcinoma | |||
Intervention | Drug: 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 Name: Torisel | |||
Study Groups/Cohorts | Temsirolimus
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma) Intervention: Drug: Temsirolimus | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 1022 | |||
Original Estimated Enrollment | 600 | |||
Actual Study Completion Date | March 2018 | |||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 99 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01210482 | |||
Other Study ID Numbers | 3066K5-4406 B1771015 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | September 2018 |