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

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

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Key information

Conditions

Carcinoma, Endometrioid Adenocarcinoma Adnexal Diseases Carcinoma Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Neoplasms mTor Protein

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

temsirolimus

Drug

Other names: Torisel

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

MedSIR

Other

Registry information

Official study title

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

Acronym: POEM

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Mar 21, 2014
Registry last updated: Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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