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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00739830
First received: August 20, 2008
Last updated: August 9, 2012
Last verified: August 2012

August 20, 2008
August 9, 2012
August 2008
February 2011   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: From randomization up to 30 months ] [ Designated as safety issue: No ]
Progression-free survival (PFS) [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00739830 on ClinicalTrials.gov Archive Site
  • The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines. [ Time Frame: From randomization to Week 16 ] [ Designated as safety issue: No ]
  • The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines [ Time Frame: From randomization to Week 26 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From randomization up to 30 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: From randomization up to 30 days after discontinuation of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)
A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
  • Drug: ridaforolimus
    40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
    Other Name: deforolimus, AP23573, MK-8669; ridaforolimus was also known as deforolimus until May 2009
  • Drug: medroxyprogesterone acetate tablets OR megestrol acetate
    oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
  • Drug: chemotherapy
    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
  • Experimental: 1
    40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
    Intervention: Drug: ridaforolimus
  • Active Comparator: 2
    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
    Interventions:
    • Drug: medroxyprogesterone acetate tablets OR megestrol acetate
    • Drug: chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
July 2012
February 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00739830
MK-8669-007, AP23573-07-205
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP