Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

NCT01210482 | Completed Results

• 2 other identifiers: 3066K5-4406B1771015
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:

1. 1.Confirmation of efficacy and safety for medical practice use.
2. 2.Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
3. 3.Investigation of the incidence status and the risk factors for interstitial lung diseases.

Conditions

Renal Cell Carcinoma

Keywords

Torisel; Regulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Drug Reactions

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening experience (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly. Relatedness to TORISEL Injection was assessed by the physician.

  96 weeks at maximum

• Number of Participants With Adverse Drug Reactions of Major Investigation Items

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. Sixteen events were evaluated as major investigation items, and the result is presented in the table.

  96 weeks at maximum

Secondary Outcomes (2)

• Overall Response Rate

  96 weeks maximum

• Response Rate Excluding Participants Evaluated as "Unassessable"

  96 weeks maximum

Study Arms (1)

Temsirolimus

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

Drug: Temsirolimus

Interventions

Temsirolimus DRUG

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.

Also known as: Torisel

Temsirolimus

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients not administered Torisel.
• Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Kyusyu University Hospital

Fukuoka, Fukuoka PREF, Japan

Location

Related Publications (1)

• 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.

  PMID: 32458996 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: August 24, 2010
• Primary Completion: March 30, 2018
• Study Completion: May 31, 2018
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)