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Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)

Primary Purpose

Leiomyosarcoma, Liposarcoma, Osteosarcoma

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 Leiomyosarcoma focused on measuring Metastatic and/or unresectable soft tissue or

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months 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 computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans) Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Minimum life expectancy of 3 months Adequate renal and hepatic function, as specified in the protocol Adequate bone marrow function, as specified in the protocol Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug Able to understand and give written informed consent Exclusion Criteria: Women who are pregnant or lactating Presence of brain metastases Prior therapy with rapamycin, rapamycin analogues or tacrolimus Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus 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 human immunodeficiency virus (HIV) infection Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus 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

    Ridaforolimus

    Arm Description

    12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks

    Outcomes

    Primary Outcome Measures

    Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)

    Secondary Outcome Measures

    Time to Tumor Progression
    Progression Free Survival
    Overall Survival
    Duration of Response
    Number of participants experiencing adverse events
    Number of participants who discontinued study drug due to adverse events
    Mean ridaforolimus blood levels within 5 minutes post intravenous infusion

    Full Information

    First Posted
    September 30, 2004
    Last Updated
    February 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00093080
    Brief Title
    Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)
    Official Title
    A Phase II Study of AP23573, An mTOR Inhibitor, in Patients With Advanced Sarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leiomyosarcoma, Liposarcoma, Osteosarcoma, Sarcoma, Soft Tissue, Metastases
    Keywords
    Metastatic and/or unresectable soft tissue or

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    216 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ridaforolimus
    Arm Type
    Experimental
    Arm Description
    12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    ridaforolimus
    Other Intervention Name(s)
    deforolimus (until May 2009), AP23573, MK-8669
    Intervention Description
    12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
    Primary Outcome Measure Information:
    Title
    Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)
    Time Frame
    Day 1 up to 4 years or discontinuation from study
    Secondary Outcome Measure Information:
    Title
    Time to Tumor Progression
    Time Frame
    Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
    Title
    Progression Free Survival
    Time Frame
    Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
    Title
    Overall Survival
    Time Frame
    Day 1 to the date of death, or the date of last contact (up to 4 years)
    Title
    Duration of Response
    Time Frame
    Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
    Title
    Number of participants experiencing adverse events
    Time Frame
    From first dose up to 30 days after last dose (up to 1 year)
    Title
    Number of participants who discontinued study drug due to adverse events
    Time Frame
    From first dose up to the last dose (up to 1 year)
    Title
    Mean ridaforolimus blood levels within 5 minutes post intravenous infusion
    Time Frame
    Day 1 and Day 5 of Cycle 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months 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 computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans) Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Minimum life expectancy of 3 months Adequate renal and hepatic function, as specified in the protocol Adequate bone marrow function, as specified in the protocol Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug Able to understand and give written informed consent Exclusion Criteria: Women who are pregnant or lactating Presence of brain metastases Prior therapy with rapamycin, rapamycin analogues or tacrolimus Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus 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 human immunodeficiency virus (HIV) infection Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22067397
    Citation
    Chawla SP, Staddon AP, Baker LH, Schuetze SM, Tolcher AW, D'Amato GZ, Blay JY, Mita MM, Sankhala KK, Berk L, Rivera VM, Clackson T, Loewy JW, Haluska FG, Demetri GD. Phase II study of the mammalian target of rapamycin inhibitor ridaforolimus in patients with advanced bone and soft tissue sarcomas. J Clin Oncol. 2012 Jan 1;30(1):78-84. doi: 10.1200/JCO.2011.35.6329. Epub 2011 Nov 7. Erratum In: J Clin Oncol. 2017 Aug 10;35(23):2722.
    Results Reference
    result

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    Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)

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