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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 : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
MedSIR

Study Description
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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

Condition or disease Intervention/treatment Phase
Carcinoma, Endometrioid mTOR Protein Drug: Temsirolimus Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).
 Drug: Temsirolimus
Other Name: Torisel


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects who have received prior anticancer therapies for the current endometrial cancer
  2. 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
  3. Prior treatment with any investigational drug within the preceding 4 weeks
  4. Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
  5. Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  6. Uncontrolled brain or leptomeningeal metastases
  7. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  8. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  9. Patients with an active, bleeding diathesis
  10. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
  11. Patients who have received prior treatment with an mTOR inhibitor
  12. Patients with a known hypersensitivity to rapamycine derivates or to its excipients
  13. History of noncompliance to medical regimens
  14. Patients unwilling to or unable to comply with the study protocol
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Barcelona, Spain
Madrid, Spain
Valencia, Spain
Sponsors and Collaborators
MedSIR
Investigators
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Principal Investigator: Andrés Poveda, Oncologist Valencia, Spain
More Information
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Responsible Party: MedSIR
ClinicalTrials.gov Identifier: NCT02093598    
Other Study ID Numbers: LLO-TEM-2011-01/TEM IIG-4
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: March 2014
Keywords provided by MedSIR:
pharmacokinetic
pharmacodynamic
Carcinoma, Endometrioid
mTOR protein
 temsirolimus
torisel
biological marker
phase II
Additional relevant MeSH terms:
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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
Genital Diseases, Female
Adenocarcinoma
Ovarian Neoplasms
 Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents