Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01210482
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0-99
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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:
| |||
| 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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2018 | |||