Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)
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ClinicalTrials.gov Identifier: NCT01420601 |
Recruitment Status :
Completed
First Posted : August 19, 2011
Last Update Posted : September 17, 2018
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Condition or disease | Intervention/treatment |
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Renal Cell Carcinoma | Drug: Temsirolimus |
Study Type : | Observational |
Actual Enrollment : | 133 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Torisel 25mg For Intravenous Drip Infusion Special Investigation - Survey On Long-term Use - |
Actual Study Start Date : | September 2011 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | March 2018 |

Group/Cohort | Intervention/treatment |
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Temsirolimus
Among the cases registered and treated in the Special Investigation, All-case Survey of temsirolimus, those continuously treated with temsirolimus for more than 24 weeks will be included.
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Drug: Temsirolimus
The usual adult dosage of this drug is 25 mg as temsirolimus once weekly by intravenous drip infusion for 30 to 60 minutes. The dosage may be appropriately reduced, depending on patient condition.
Other Name: Torisel |
- Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 96 weeks ]
- The onset of interstitial lung disease in long-term use [ Time Frame: 96 weeks ]
- The incidence of adverse events in long-term use [ Time Frame: 96 weeks ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
- Among patients registered and treated in the Special Investigation, All-case Survey of Torisel, those continuously treated with Torisel for more than 24 weeks will be included.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420601
Japan | |
Kinki University Hospital | |
Osakasayama, Osaka, Japan, 589-8511 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01420601 History of Changes |
Other Study ID Numbers: |
B1771016 |
First Posted: | August 19, 2011 Key Record Dates |
Last Update Posted: | September 17, 2018 |
Last Verified: | September 2018 |
Keywords provided by Pfizer:
Torisel Long-term use Regulatory Post Marketing Commitment Plan |
Additional relevant MeSH terms:
Carcinoma, Renal Cell Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Everolimus Sirolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |