Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma
- Conditions
- Health Condition 1: null- Endometrial Cancer
- Registration Number
- CTRI/2009/091/000160
- Lead Sponsor
- ARIAD Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
18 years of age or older - Endometrial cancer - Patients must have been treated with one cytotoxic regimen - 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 18 years of age or older - Endometrial cancer - Patients must have been treated with one cytotoxic regimen - 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.
More than one prior regimen of cytotoxic chemotherapy - 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)Timepoint: Time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first)
- Secondary Outcome Measures
Name Time Method 1.Progression-free survival of patients receiving deforolimum versus progestin.<br><br>2.Overall survival of patients receiving deforolimus versus progestin<br><br>3.Best response rates in patients receiving deforolimus versus progestin<br><br>4.Safety and tolerability of oral deforolimusTimepoint: Comparison of progression-free survival of patients receiving deforolimum versus progestin at 16 weeks and 26 weeks post-randomization.<br><br>