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Last Updated: January 24, 2020

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CLINICAL TRIALS PROFILE FOR TEMSIROLIMUS

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505(b)(2) Clinical Trials for Temsirolimus

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT02093598 POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus Completed MedSIR Phase 2 2012-05-01 Type of Application: Clinical trial of new indication. Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09. Primary Objective: - To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus. - This is an exploratory clinical study. No efficacy objectives are included in this clinical trial. Secondary Objectives: - To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus. - To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR), - To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status. - To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure - To collect data about the differences in expression profile, assessed by RNA microarrays
New Combination NCT03571438 Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors Recruiting University Hospital, Grenoble N/A 2017-10-16 The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation of the University Hospital of Grenoble and to compare their efficacy with that of currently selected treatments in the clinic. The population targeted by the combination for use in clinical practice is patients with metastatic clear cell renal cell carcinoma. Current treatments for these patients are Sunitinib, Pazopanib and Temsirolimus.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Temsirolimus

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003712 CCI-779 in Treating Patients With Advanced Solid Tumors Completed National Cancer Institute (NCI) Phase 1 2001-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00003712 CCI-779 in Treating Patients With Advanced Solid Tumors Completed University of Texas Phase 1 2001-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00003712 CCI-779 in Treating Patients With Advanced Solid Tumors Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2001-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00003712 CCI-779 in Treating Patients With Advanced Solid Tumors Completed The University of Texas Health Science Center at San Antonio Phase 1 2001-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
NCT00012142 CCI-779 in Treating Patients With Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2000-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating patients who have progressive prostate cancer.
NCT00012142 CCI-779 in Treating Patients With Prostate Cancer Completed Jonsson Comprehensive Cancer Center Phase 2 2000-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating patients who have progressive prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Temsirolimus

Condition Name

Condition Name for Temsirolimus
Intervention Trials
Renal Cell Carcinoma 13
Unspecified Adult Solid Tumor, Protocol Specific 10
Advanced Cancer 10
Kidney Cancer 8
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Condition MeSH

Condition MeSH for Temsirolimus
Intervention Trials
Carcinoma 47
Carcinoma, Renal Cell 41
Lymphoma 25
Neoplasms 23
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Clinical Trial Locations for Temsirolimus

Trials by Country

Trials by Country for Temsirolimus
Location Trials
United States 925
Canada 88
Germany 37
France 29
Australia 25
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Trials by US State

Trials by US State for Temsirolimus
Location Trials
Texas 58
California 45
New York 42
Pennsylvania 39
Illinois 38
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Clinical Trial Progress for Temsirolimus

Clinical Trial Phase

Clinical Trial Phase for Temsirolimus
Clinical Trial Phase Trials
Phase 4 3
Phase 3 8
Phase 2 90
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Clinical Trial Status

Clinical Trial Status for Temsirolimus
Clinical Trial Phase Trials
Completed 102
Active, not recruiting 42
Terminated 25
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Clinical Trial Sponsors for Temsirolimus

Sponsor Name

Sponsor Name for Temsirolimus
Sponsor Trials
National Cancer Institute (NCI) 82
Pfizer 31
Wyeth is now a wholly owned subsidiary of Pfizer 24
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Sponsor Type

Sponsor Type for Temsirolimus
Sponsor Trials
Other 168
Industry 100
NIH 83
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