search
Back to results

AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ridaforolimus
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial, Cancer

Eligibility Criteria

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

Inclusion Criteria: ≥18 years of age with histologically confirmed endometrial cancer Documented progression of endometrial cancer (e.g., within the last 3 months) If of childbearing potential, must agree to use approved barrier methods of contraception (non hormonal methods) Presence of at least one measurable lesion that can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans). Previously irradiated lesions may be considered to be measurable provided: *there has been documented progression of the lesion(s) since completion of radiotherapy; and *the criteria for measurability as outlined above are met. ECOG performance status ≤ 2 Minimum life expectancy of 3 months Adequate renal and hepatic function, defined as: Total serum bilirubin ≤ 1.5 x ULN for the institution; AST and/or ALT ≤ 2 x ULN for the institution; Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline phosphatase liver fraction must be < 1.5 ULN); Serum albumin ≥ 2.5 g/dL; Serum creatinine ≤ 1.5 x ULN for the institution. Adequate bone marrow function, defined as: ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L. Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL Able to understand and give written informed consent Exclusion Criteria: Women who are pregnant or lactating Presence of brain metastases More than 2 prior regimens of cytotoxic chemotherapy or enzyme inhibitor therapy Prior therapy with rapamycin, rapamycin analogues or tacrolimus; or known sensitivity to these agents Anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response modifiers, signal transduction inhibitors, etc.) within 4 weeks prior to the first dose of AP23573. The interval may be ≥ 2 weeks for hormonal therapy or signal transduction inhibitors with a half-life known to be <24 hours and must be ≥ 6 weeks for nitrosourea or mitomycin. Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ Grade 1 by National Cancer Institute [NCI] toxicity criteria) Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ) Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin) Significant uncontrolled cardiovascular disease Active infection requiring systemic therapy Known HIV infection Treatment with any investigational agent within 4 weeks prior to the first dose of AP23573 Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug. Nasal, ophthalmic, and topical glucocorticoid preparations are allowed as well as low dose maintenance steroid therapy for other conditions. Physiologic hormone replacement therapy (e.g., thyroid supplementation for thyroid deficiency or oral replacement glucocorticoid therapy for adrenal insufficiency) is allowed. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573. Patients who have recovered from placement of a central venous access port within 2 weeks of Cycle 1, Day 1 will be considered eligible. Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks. A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.

    Outcomes

    Primary Outcome Measures

    The primary objective of the study is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.

    Secondary Outcome Measures

    Assess the safety and tolerability of this study drug regimen in this patient population
    Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival and duration of response
    Examine pharmacokinetic characteristics of AP23573

    Full Information

    First Posted
    July 21, 2005
    Last Updated
    February 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00122343
    Brief Title
    AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED)
    Official Title
    A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open-label nonrandomized multi-center study designed to evaluate the effect of AP23573 in patients with recurrent or persistent endometrial cancer. The primary objective is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks. A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    ridaforolimus
    Other Intervention Name(s)
    deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
    Intervention Description
    AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks. A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
    Primary Outcome Measure Information:
    Title
    The primary objective of the study is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.
    Time Frame
    Duration of the study
    Secondary Outcome Measure Information:
    Title
    Assess the safety and tolerability of this study drug regimen in this patient population
    Time Frame
    Duration of the study
    Title
    Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival and duration of response
    Time Frame
    Duration of the study
    Title
    Examine pharmacokinetic characteristics of AP23573
    Time Frame
    Duration of the study

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥18 years of age with histologically confirmed endometrial cancer Documented progression of endometrial cancer (e.g., within the last 3 months) If of childbearing potential, must agree to use approved barrier methods of contraception (non hormonal methods) Presence of at least one measurable lesion that can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans). Previously irradiated lesions may be considered to be measurable provided: *there has been documented progression of the lesion(s) since completion of radiotherapy; and *the criteria for measurability as outlined above are met. ECOG performance status ≤ 2 Minimum life expectancy of 3 months Adequate renal and hepatic function, defined as: Total serum bilirubin ≤ 1.5 x ULN for the institution; AST and/or ALT ≤ 2 x ULN for the institution; Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline phosphatase liver fraction must be < 1.5 ULN); Serum albumin ≥ 2.5 g/dL; Serum creatinine ≤ 1.5 x ULN for the institution. Adequate bone marrow function, defined as: ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L. Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL Able to understand and give written informed consent Exclusion Criteria: Women who are pregnant or lactating Presence of brain metastases More than 2 prior regimens of cytotoxic chemotherapy or enzyme inhibitor therapy Prior therapy with rapamycin, rapamycin analogues or tacrolimus; or known sensitivity to these agents Anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response modifiers, signal transduction inhibitors, etc.) within 4 weeks prior to the first dose of AP23573. The interval may be ≥ 2 weeks for hormonal therapy or signal transduction inhibitors with a half-life known to be <24 hours and must be ≥ 6 weeks for nitrosourea or mitomycin. Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ Grade 1 by National Cancer Institute [NCI] toxicity criteria) Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ) Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin) Significant uncontrolled cardiovascular disease Active infection requiring systemic therapy Known HIV infection Treatment with any investigational agent within 4 weeks prior to the first dose of AP23573 Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug. Nasal, ophthalmic, and topical glucocorticoid preparations are allowed as well as low dose maintenance steroid therapy for other conditions. Physiologic hormone replacement therapy (e.g., thyroid supplementation for thyroid deficiency or oral replacement glucocorticoid therapy for adrenal insufficiency) is allowed. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573. Patients who have recovered from placement of a central venous access port within 2 weeks of Cycle 1, Day 1 will be considered eligible. Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank Haluska, M.D., Ph.D.
    Organizational Affiliation
    Ariad Pharmaceuticals
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23403817
    Citation
    Colombo N, McMeekin DS, Schwartz PE, Sessa C, Gehrig PA, Holloway R, Braly P, Matei D, Morosky A, Dodion PF, Einstein MH, Haluska F. Ridaforolimus as a single agent in advanced endometrial cancer: results of a single-arm, phase 2 trial. Br J Cancer. 2013 Mar 19;108(5):1021-6. doi: 10.1038/bjc.2013.59. Epub 2013 Feb 12.
    Results Reference
    result

    Learn more about this trial

    AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED)

    We'll reach out to this number within 24 hrs