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

NCT02093598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-11-27

No results posted yet for this study

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

Conditions

  • Carcinoma, Endometrioid
  • mTOR Protein

Interventions

DRUG

Temsirolimus

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Principal Investigators

  • Andrés Poveda, Oncologist · Valencia, Spain

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02093598 on ClinicalTrials.gov