EUCTR2008-006979-72-PL进行中（未招募）不适用
A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients with Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- •1. Female patients 18 years or older
- •2. Patients must have a diagnosis of histologically or cytologically confirmed epithelial
- •ovarian, fallopian tube, or primary peritoneal carcinoma.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •4. Patients who:
- •Are postmenopausal for at least 1 year before the screening visit, OR
- •Are surgically sterile, OR
- •If they are of childbearing potential, agree to practice 2 effective methods of nonhormonal contraception, at the same time, from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
- •5. The patient or the patient’s legal representative is able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- •6. Clinical laboratory values as specified below within 7 days before study entry:
- •Absolute neutrophil count (ANC) = 1,500/µL
- •Platelet count =100,000/ µL
- •Total bilirubin must be less than 1.5 times the upper limit of the normal range
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be
- •= 2.5 times the ULN. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in liver.
- •Creatinine clearance as calculated by the method of Cockroft and Gault = 30 mL/minute.
- •7. Platinum-refractory malignant disease or platinum-resistant malignant disease:
- •Platinum-refractory malignant disease, characterized by a lack of response, progression, or recurrence of malignant disease during treatment with a platinum-based treatment regimen; OR
- •Platinum-resistant malignant disease, characterized by progression or recurrence
- •of malignant disease within 6 months after the last dose of platinum on a platinum-based treatment regimen
- •8. Measurable neoplastic disease according to the RECIST criteria, ie, 1 or more
- •lesions that can be accurately measured in at least 1 dimension (longest dimension to be recorded) and at least 2 cm by conventional techniques or at least 1 cm by spiral CT scan and at least 1 target lesion to assess response. Tumors within a previously irradiated field are considered nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence of malignancy 90 days or more following completion of radiotherapy.
- •A CA 125 level of > 40 units/mL AND clinical evidence of neoplastic disease
- •(eg, ascites, pleural effusion, peritoneal implantation, etc). Patients who simply have
- •an elevated CA 125 level without clinical evidence of neoplastic disease are NOT eligible for the study.
- •9. Recovered (ie, = Grade 1 toxicity or patient’s baseline status) from the reversible
- •effects of prior antineoplastic therapy
- •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
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •1. Pregnant or lactating
- •2. Any serious medical or psychiatric illness that could, in the investigator’s opinion,
- •potentially interfere with the completion of treatment according to this protocol
- •3. Treatment with any investigational products within 28 days before the first dose of
- •4. Receipt of more than 4 regimens of prior systemic therapy, 2 of which may be platinum-based cytotoxic chemotherapy, 1 of which may be a nonplatinum cytotoxic
- •regimen, and 1 biological therapy NOT part of a cytotoxic regimen
- •5. Known CNS metastases
- •6. Prior allogeneic bone marrow or organ transplantation
- •7. Radiotherapy within 21 days preceding the first dose of study drug
- •8. Radiotherapy to more than 25% of the hematopoietically active bone marrow
- •9. Major surgery within 14 days preceding the first dose of study drug
- •10. Infection requiring systemic antibiotic therapy within 14 days preceding the first
- •dose of study drug, or other severe infection
- •11. Inability to swallow orally administered medication
- •12. Diagnosis or treatment of another malignancy within 2 years preceding the first dose of study drug except for nonmelanoma skin cancer that has been completely
- •resected, or any in situ malignancy that has been completely resected
- •13. Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
- •hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
研究者
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