Clinical Trial: POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: "A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma"

Brief Summary:

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