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Torisel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)


Phase 4
N/A
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

Torisel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)


Implemented as a Drug Use Investigation by Central Registration System


Inclusion Criteria:



- Patients treated with Torisel (patients with metastatic and/or radically unresectable
or advanced renal cell carcinoma).

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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The incidence of adverse events

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

3066K5-4406

NCT ID:

NCT01210482

Start Date:

October 2010

Completion Date:

August 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Torisel
  • Regulatory Post Marketing Commitment Plan
  • Carcinoma
  • Carcinoma, Renal Cell

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