Carcinoma, EndometrioidPhase 2POEMNCT02093598
POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus
A Phase 2 study testing Temsirolimus in people with Carcinoma, Endometrioid and mTOR Protein, run by MedSIR at 3 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Endometrioid, mTOR Protein
- What is being tested?
- Temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesSpain
- Study dates
- May 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate renal function
- Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN
- Signed informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: "A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma"
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.
Read more
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
- Being tested
- Temsirolimus
- Keywords
- pharmacokinetic, pharmacodynamic, Carcinoma, Endometrioid, mTOR protein, temsirolimus, torisel, biological marker, phase II
- Medical subject headings
- Carcinoma, Endometrioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Also called Torisel
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Experimental | 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Receives: Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after last dose of the last patient
Secondary outcomes (1)
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
Measured: 1 month after the surgery of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, EndometrioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrés Poveda, Oncologist, Principal investigator, Valencia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093598
- Sponsor's protocol ID
- LLO-TEM-2011-01/TEM IIG-4
- Other IDs
- 2011-005031-96
- Acronym
- POEM
- Status last verified
- Mar 2014
- First submitted
- 11 Feb 2014
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma"
- ClinicalTrials.gov ID
- NCT02093598
- Acronym / sponsor ID
- POEM / LLO-TEM-2011-01/TEM IIG-4
- Conditions
- Carcinoma, Endometrioid, mTOR Protein
- Keywords
- pharmacokinetic, pharmacodynamic, Carcinoma, Endometrioid, mTOR protein, temsirolimus, torisel, biological marker, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Experimental | Drug: Temsirolimus25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusAlso: Torisel | Drug | Temsirolimus |
Primary outcome
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.
1 secondary outcome
To evaluate if mTOR inhibition is associated with changes in tumor-tissue
Time frame: 1 month after the surgery of the last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrés Poveda, Oncologist principal investigator
Valencia, Spain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temsirolimus in people with Carcinoma, Endometrioid and mTOR Protein, run by MedSIR at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.