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Last Updated: July 5, 2020

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CLINICAL TRIALS PROFILE FOR TORISEL

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505(b)(2) Clinical Trials for Torisel

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
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Torisel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00016328 CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme Completed National Cancer Institute (NCI) Phase 2 2001-05-01 Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00028028 CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer Completed National Cancer Institute (NCI) Phase 2 2002-02-01 Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
NCT00033267 CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma Completed National Cancer Institute (NCI) Phase 2 2002-04-01 Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
NCT00072176 Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer Completed National Cancer Institute (NCI) Phase 2 2004-05-01 This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Torisel

Condition Name

Condition Name for Torisel
Intervention Trials
Advanced Cancer 7
Adult Gliosarcoma 6
Adult Glioblastoma 6
Adult Giant Cell Glioblastoma 6
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Condition MeSH

Condition MeSH for Torisel
Intervention Trials
Carcinoma 26
Carcinoma, Renal Cell 19
Lymphoma 16
Neoplasms 14
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Clinical Trial Locations for Torisel

Trials by Country

Trials by Country for Torisel
Location Trials
United States 732
Canada 46
Japan 19
France 19
Australia 18
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Trials by US State

Trials by US State for Torisel
Location Trials
Texas 47
California 32
Pennsylvania 29
Illinois 28
Minnesota 27
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Clinical Trial Progress for Torisel

Clinical Trial Phase

Clinical Trial Phase for Torisel
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 56
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Clinical Trial Status

Clinical Trial Status for Torisel
Clinical Trial Phase Trials
Completed 66
Active, not recruiting 24
Recruiting 14
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Clinical Trial Sponsors for Torisel

Sponsor Name

Sponsor Name for Torisel
Sponsor Trials
National Cancer Institute (NCI) 67
M.D. Anderson Cancer Center 18
Pfizer 17
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Sponsor Type

Sponsor Type for Torisel
Sponsor Trials
Other 78
NIH 67
Industry 46
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