CLINICAL TRIALS PROFILE FOR TORISEL
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505(b)(2) Clinical Trials for TORISEL
| 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 | >Sponsor | >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 | >Sponsor | >Phase | >Start Date | >Summary |
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