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Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ridaforolimus
medroxyprogesterone acetate tablets OR megestrol acetate
chemotherapy
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

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • Endometrial cancer
  • Patients must have been treated with at least one line of chemotherapy, but not more than two lines of chemotherapy, and experienced progressive disease
  • At least one measurable lesion
  • ECOG performance status less than or equal to 1
  • Minimum life expectancy of 3 months
  • Adequate renal and hepatic function
  • Adequate bone marrow function
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Able to understand and give written informed consent
  • Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given

Exclusion Criteria:

  • Two lines of chemotherapy for recurrent or metastatic disease
  • Chemotherapy for recurrent or metastatic disease administered within six months of adjuvant therapy
  • More than two lines of chemotherapy of any type
  • Prior therapy with hormonal agents
  • Women who are pregnant or lactating
  • Presence of brain or other central nervous system metastases
  • Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents
  • Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization
  • Ongoing toxicity associated with prior anticancer therapy
  • Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization.
  • Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  • Known Grade 3 or 4 hypersensitivity to macrolide antibiotics
  • Significant uncontrolled cardiovascular disease
  • Active infection
  • Known HIV infection
  • Known Hepatitis B or C infection
  • Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes
  • Concurrent treatment with immunosuppressive agents
  • A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus

    Investigator's choice of: oral medroxyprogesterone acetate tablets 200 mg daily or oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily) OR Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator

    Outcomes

    Primary Outcome Measures

    Progression-free survival (PFS)

    Secondary Outcome Measures

    The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.
    The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines
    Overall survival
    Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression
    Safety and tolerability

    Full Information

    First Posted
    August 20, 2008
    Last Updated
    June 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00739830
    Brief Title
    Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)
    Official Title
    A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus or the investigators' choice of progestin or chemotherapy.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Investigator's choice of: oral medroxyprogesterone acetate tablets 200 mg daily or oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily) OR Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator
    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
    40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
    Intervention Type
    Drug
    Intervention Name(s)
    medroxyprogesterone acetate tablets OR megestrol acetate
    Intervention Description
    oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
    Intervention Type
    Drug
    Intervention Name(s)
    chemotherapy
    Intervention Description
    Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator
    Primary Outcome Measure Information:
    Title
    Progression-free survival (PFS)
    Time Frame
    From randomization up to 30 months
    Secondary Outcome Measure Information:
    Title
    The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.
    Time Frame
    From randomization to Week 16
    Title
    The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines
    Time Frame
    From randomization to Week 26
    Title
    Overall survival
    Time Frame
    From randomization up to 30 months
    Title
    Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression
    Time Frame
    From randomization up to 30 months
    Title
    Safety and tolerability
    Time Frame
    From randomization up to 30 days after discontinuation of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Endometrial cancer Patients must have been treated with at least one line of chemotherapy, but not more than two lines of chemotherapy, and experienced progressive disease At least one measurable lesion ECOG performance status less than or equal to 1 Minimum life expectancy of 3 months Adequate renal and hepatic function Adequate bone marrow function Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL Able to understand and give written informed consent Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given Exclusion Criteria: Two lines of chemotherapy for recurrent or metastatic disease Chemotherapy for recurrent or metastatic disease administered within six months of adjuvant therapy More than two lines of chemotherapy of any type Prior therapy with hormonal agents Women who are pregnant or lactating Presence of brain or other central nervous system metastases Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization Ongoing toxicity associated with prior anticancer therapy Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization. Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ) Known Grade 3 or 4 hypersensitivity to macrolide antibiotics Significant uncontrolled cardiovascular disease Active infection Known HIV infection Known Hepatitis B or C infection Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes Concurrent treatment with immunosuppressive agents A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26077241
    Citation
    Oza AM, Pignata S, Poveda A, McCormack M, Clamp A, Schwartz B, Cheng J, Li X, Campbell K, Dodion P, Haluska FG. Randomized Phase II Trial of Ridaforolimus in Advanced Endometrial Carcinoma. J Clin Oncol. 2015 Nov 1;33(31):3576-82. doi: 10.1200/JCO.2014.58.8871. Epub 2015 Jun 15.
    Results Reference
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    Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)

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