A Randomized Phase II trial of Ridaforolimus (AP23573; MK-8669) compared to Progestin or Chemotherapy in female adult patients with advanced Endometrial Carcinoma

ARIAD Pharmaceuticals Inc0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

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•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)

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