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

An observational study of Renal Cell Carcinoma, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 15 to 99 years
Conditions the study is for: Renal Cell Carcinoma
What is being tested?: Temsirolimus
Type of treatment: Injection or infusion
How many people: 1,050 participants
Where: 1 siteJapan
Study dates: 24 Aug 2010to 31 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Kyusyu University Hospital
Fukuoka, Fukuoka PREF

Other trials in Japan

About this study

Official title: SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -

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

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

Read the detailed description

Implemented as a Drug Use Investigation by Central Registration System

Conditions: Renal Cell Carcinoma
Being tested: Temsirolimus
Keywords: Torisel, Regulatory Post Marketing Commitment Plan
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TemsirolimusDrug
Also called Torisel
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.

Study groups in NCT01210482
Study group	Role	What they receive
Temsirolimus		Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma) Receives: Drug: Temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 96 weeks at maximum

Secondary outcomes (2)

Overall Response Rate
Clinical response was assessed based on the following 4 classes with reference to the "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version:" complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD). The overall response rate, which was defined as the percentage of participants who achieved CR or PR over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% confidence interval.
Measured: 96 weeks maximum
Response Rate Excluding Participants Evaluated as "Unassessable"
Clinical response was assessed based on the following 4 classes with reference to the "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version:" complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD). The percentage of participants who achieved CR or PR over the total number of assessable effectiveness analysis population excluding those evaluated as "unassessable," was calculated.
Measured: 96 weeks maximum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201031 May 2018

First posted28 Sep 2010 (estimated)
Study start24 Aug 2010
Primary completion30 Mar 2018
Study completion31 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,050 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01210482
Sponsor's protocol ID: 3066K5-4406
Other IDs: B1771015
Status last verified: Jun 2024
First submitted: 27 Sep 2010
Last updated: 25 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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.
PubMed 32458996

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -
ClinicalTrials.gov ID: NCT01210482
Acronym / sponsor ID: 3066K5-4406
Conditions: Renal Cell Carcinoma
Keywords: Torisel, Regulatory Post Marketing Commitment Plan
Study type: Observational
Recruitment status: Completed
Enrolment: 1,050 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 24 Aug 2010 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 28 Sep 2010 (estimated)
Results: Posted 25 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Detailed description

Implemented as a Drug Use Investigation by Central Registration System

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Temsirolimus	–	Drug: TemsirolimusPatients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)

Who may qualify

Ages: 15 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TemsirolimusAlso: ToriselThe 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.	Drug	Temsirolimus

Primary outcome

Number of Participants With Adverse Drug Reactions
Time frame: 96 weeks at maximum
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.
Number of Participants With Adverse Drug Reactions of Major Investigation Items
Time frame: 96 weeks at maximum
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.

2 secondary outcomes

Overall Response Rate
Time frame: 96 weeks maximum
Response Rate Excluding Participants Evaluated as "Unassessable"
Time frame: 96 weeks maximum

Results and safety

Results posted to the registry on 25 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TORISEL Injection (Temsirolimus)	1,050	1,001

Primary outcome: Number of Participants With Adverse Drug Reactions

Time frame: 96 weeks at maximum. Number. Unit: Participants

Measure	TORISEL Injection (Temsirolimus) n = 1001
ADR	778
Serious ADR	352

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once.

Primary outcome: Number of Participants With Adverse Drug Reactions of Major Investigation Items

Time frame: 96 weeks at maximum. Number. Unit: Participants

Measure	TORISEL Injection (Temsirolimus) n = 1001
Mucositis related adverse events	279
Skin disorder	209
Interstitial lung disease	174
Interstitial lung disease suspected events	3
Infections	141
Hypercholesterolaemia/hyperlipidaemia	140
Diabetes/hyperglycaemia	131
Diarrhoea	43

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 96 weeks maximum. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TORISEL Injection (Temsirolimus)	499 of 1,001 (49.9%)	759 of 1,001 (75.8%)	185 of 1,001

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32458996Sugiyama 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Renal Cell Carcinoma

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
RecruitingPhase 3
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Carcinoma, Renal Cell

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (time frame: 96 weeks at maximum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01210482, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.