A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
1
40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
干预措施: ridaforolimus (Drug)
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
干预措施: medroxyprogesterone acetate tablets OR megestrol acetate (Drug)
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
干预措施: chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization up to 30 months
次要结局
- Overall survival(From randomization up to 30 months)
- The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.(From randomization to Week 16)
- The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines(From randomization to Week 26)
- Safety and tolerability(From randomization up to 30 days after discontinuation of treatment)
- Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression(From randomization up to 30 months)