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

Primary Purpose

Carcinoma, Endometrioid, mTOR Protein

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Temsirolimus

About this trial

This is an interventional other trial for Carcinoma, Endometrioid focused on measuring pharmacokinetic, pharmacodynamic, Carcinoma, Endometrioid, mTOR protein, temsirolimus, torisel, biological marker, phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically-confirmed endometrial cancer
Stage I - II (grade 1, 2 or 3), candidates for surgery as the primary treatment
Age ≥ 18 years
WHO performance status ≤ 2
Adequate bone marrow function
Adequate liver function
Adequate renal function
Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN
Signed informed consent

Exclusion Criteria:

Subjects who have received prior anticancer therapies for the current endometrial cancer
Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
Prior treatment with any investigational drug within the preceding 4 weeks
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
Uncontrolled brain or leptomeningeal metastases
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Patients with an active, bleeding diathesis
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
Patients who have received prior treatment with an mTOR inhibitor
Patients with a known hypersensitivity to rapamycine derivates or to its excipients
History of noncompliance to medical regimens
Patients unwilling to or unable to comply with the study protocol

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temsirolimus

Arm Description

25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).

Outcomes

Primary Outcome Measures

To evaluate the mTOR inhibitor effects of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.

To evaluate the mTOR inhibitor effects, assessed by level 4EBP1 and S6K1, of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.

Secondary Outcome Measures

To evaluate if mTOR inhibition is associated with changes in tumor-tissue

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

Full Information

NCT ID

NCT02093598

First Posted

February 11, 2014

Last Updated

November 25, 2020

Sponsor

MedSIR

1. Study Identification

Unique Protocol Identification Number

NCT02093598

Brief Title

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

Acronym

POEM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedSIR

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Endometrioid, mTOR Protein

Keywords

pharmacokinetic, pharmacodynamic, Carcinoma, Endometrioid, mTOR protein, temsirolimus, torisel, biological marker, phase II

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temsirolimus

Arm Type

Experimental

Arm Description

25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).

Intervention Type

Drug

Intervention Name(s)

Temsirolimus

Other Intervention Name(s)

Torisel

Primary Outcome Measure Information:

Title

To evaluate the mTOR inhibitor effects of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.

Description

To evaluate the mTOR inhibitor effects, assessed by level 4EBP1 and S6K1, of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.

Time Frame

1 month after last dose of the last patient

Secondary Outcome Measure Information:

Title

To evaluate if mTOR inhibition is associated with changes in tumor-tissue

Description

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

Time Frame

1 month after the surgery of the last patient

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically-confirmed endometrial cancer Stage I - II (grade 1, 2 or 3), candidates for surgery as the primary treatment Age ≥ 18 years WHO performance status ≤ 2 Adequate bone marrow function Adequate liver function Adequate renal function Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN Signed informed consent Exclusion Criteria: Subjects who have received prior anticancer therapies for the current endometrial cancer Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study Prior treatment with any investigational drug within the preceding 4 weeks Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period Uncontrolled brain or leptomeningeal metastases Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study Patients with an active, bleeding diathesis Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods Patients who have received prior treatment with an mTOR inhibitor Patients with a known hypersensitivity to rapamycine derivates or to its excipients History of noncompliance to medical regimens Patients unwilling to or unable to comply with the study protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrés Poveda, Oncologist

Organizational Affiliation

Valencia, Spain

Official's Role

Principal Investigator

Facility Information:

City

Barcelona

Country

Spain

City

Madrid

Country

Spain

City

Valencia

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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