POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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