Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02093598
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2014-02-11
Brief Title:
POEM STUDY A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus Targeting the mTOR Pathway in Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POEM
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-005031-96 | EUDRACT_NUMBER | None | None |