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.
- 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.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 * | Not Provided | |||
| * 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 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
