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