EUCTR2008-000634-53-IT进行中（未招募）不适用
A randomized phase II trial of deforolimus (AP23573; MK-8669) compared to progestin in female adult patients with advanced endometrial carcinoma following one line of chemotherapy - AP23573-07-205
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Eligible patients will have the following characteristics: 1. Major equal to 18 years of age. 2. Patients must have unresectable stage III or IVa, or metastatic (stage IVb), or recurrent histologically-confirmed endometrial cancer. 3. Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma, and carcinosarcomas. Leiomyosarcomas are not included. 4. Patients must have been treated with one cytotoxic regimen either: 1. As first line therapy for recurrent or metastatic disease, with documented disease progression after treatment, or 2. As adjuvant therapy, in which case the patient must have documented disease recurrence <6 months after the end of therapy. 5. The patient must have at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter Major equal to 20 mm using conventional techniques or Major equal to 10 mm with spiral CT scan (or otherwise at least twice the reconstruction interval for CT or MRI scans). Previously irradiated lesions may be considered to be measurable provided: 1) there has been documented progression of the lesion(s) since completion of radiotherapy, and 2) the criteria for measurability as outlined above are met. 6. ECOG performance status minor equal to 1. 7. Minimum life expectancy of 3 months. 8. Adequate renal and hepatic function, defined as: Total serum bilirubin minor equal to institutional ULN unless patient has Gilbert?s syndrome in which case direct bilirubin must be minor equal to ULN for the institution. AST and/or ALT minor equal to 2.5 x ULN for the institution. (or minor equal to 5 x ULN if liver metastases are present) Alkaline phosphatase minor equal to 1.5 x ULN for the institution (if major of 1.5 x ULN, then alkaline phosphatase liver fraction must be minor equal to 1.5 ULN). Serum creatinine minor equal to 1.5 x ULN for the institution (or calculated creatinine clearance major equal to 50 mL/min/1.73 m2) 9. Adequate bone marrow function, defined as: Total leukocytes major equal to 3.0 x 109/L. ANC major equal to 1.5 x 109/L. Platelet count major equal to 100 x 109/L. 10. Serum cholesterol minor of 350 mg/dL and triglycerides minor of 400 mg/dL. 11. Able to understand and give written informed consent. 12. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment and must use an approved contraceptive method as appropriate from time of study screening until 30 days after the last dose of study drug. Non hormonal methods must be used. Approved contraceptive methods, intra-uterine device, diaphragm with spermicide, cervical cap with spermicide or female condom with spermicide. (Spermicides alone are not an acceptable method of contraception.) .
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following exclusion criteria will apply: 1. More than one prior regimen of cytotoxic chemotherapy. 2. Prior therapy with hormonal agents for endometrial cancer. 3. Women who are pregnant or lactating. 4. Presence of brain or other central nervous system metastases. 5. Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents 6. Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization. The interval must be major equal to 6 weeks for prior nitrosourea or mitomycin therapy. 7. Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of minor equal to grade 1 by NCI toxicity criteria). 8. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization. Patients who have recovered from placement of a central venous access port within 2 weeks of Cycle 1 Day 1 will be considered eligible. 9. Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ). 10. Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin). 11. Significant uncontrolled cardiovascular disease including NYHA class III-IV heart failure, unstable angina, or a myocardial infarction within the last six months. 12. Active infection requiring systemic therapy. 13. Known HIV infection. 14. Known hepatitis B or C infection. 15. Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes. 16. Concurrent treatment with immunosuppressive agents . 17. Patient has a requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A). Patients should be off these medications major equal to 2 weeks prior to the first dose of deforolimus. 18. Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient?s safety or interfere with evaluating the safety of the study drug.
研究者
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