POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus (POEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02093598|
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : April 14, 2015
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.
- 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.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Endometrioid mTOR Protein||Drug: Temsirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma"|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).
Other Name: Torisel
- To evaluate the mTOR inhibitor effects of temsirolimus directly on endometrial tumor tissue after four weeks of therapy. [ Time Frame: 1 month after last dose of the last patient ]To evaluate the mTOR inhibitor effects, assessed by level 4EBP1 and S6K1, of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.
- To evaluate if mTOR inhibition is associated with changes in tumor-tissue [ Time Frame: 1 month after the surgery of the last patient ]
To evaluate if mTOR inhibition is associated with changes in tumor-tissue:
- Signal transduction: AKT and PTEN
- c-MYC, cyclin D activity
- Proliferation index analysis: p53, p27, BAD, Bcl-2 and ki-67
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093598
|Principal Investigator:||Andrés Poveda, Oncologist||Valencia, Spain|