POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus (POEM)
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ClinicalTrials.gov Identifier: NCT02093598 |
Recruitment Status :
Completed
First Posted : March 21, 2014
Last Update Posted : November 27, 2020
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Endometrioid mTOR Protein | Drug: Temsirolimus | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | "A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma" |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Temsirolimus
25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).
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Drug: Temsirolimus
Other Name: Torisel |
- To evaluate the mTOR inhibitor effects of temsirolimus directly on endometrial tumor tissue after four weeks of therapy. [ Time Frame: 1 month after last dose of the last patient ]To evaluate the mTOR inhibitor effects, assessed by level 4EBP1 and S6K1, of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.
- To evaluate if mTOR inhibition is associated with changes in tumor-tissue [ Time Frame: 1 month after the surgery of the last patient ]
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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093598
Spain | |
Barcelona, Spain | |
Madrid, Spain | |
Valencia, Spain |
Principal Investigator: | Andrés Poveda, Oncologist | Valencia, Spain |
Responsible Party: | MedSIR |
ClinicalTrials.gov Identifier: | NCT02093598 |
Other Study ID Numbers: |
LLO-TEM-2011-01/TEM IIG-4 2011-005031-96 ( EudraCT Number ) |
First Posted: | March 21, 2014 Key Record Dates |
Last Update Posted: | November 27, 2020 |
Last Verified: | March 2014 |
pharmacokinetic pharmacodynamic Carcinoma, Endometrioid mTOR protein |
temsirolimus torisel biological marker phase II |
Carcinoma Endometrial Neoplasms Carcinoma, Endometrioid Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Adenocarcinoma Ovarian Neoplasms |
Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Sirolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |