EUCTR2012-001576-12-GB进行中（未招募）1 期
A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects with Platinum-Resistant Recurrent Ovarian Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
入选标准
- •1. Subjects who are women 18 years of age or older.
- •2. Subjects who have histologically or cytologically confirmed recurrent high-grade serous, endometriod, mixed cell, or clear cell epithelial ovarian cancer (Grade 2 or 3); primary peritoneal carcinomatosis; or fallopian tube cancer.
- •3. Subjects who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen). There is no limit on the number of prior treatment regimens.
- •4. Subjects must have had prior paclitaxel treatment.
- •5. Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable disease.
- •A. Detectable disease is defined in a subject as one who does not have measurable disease but has baseline values of CA-125 at least twice the upper limit of normal (ULN) and has at least one of the following conditions: (1) ascites and/or pleural effusion attributed to tumor or (2) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions.
- •6. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •7. Subjects with acceptable organ function, as evidenced by laboratory data:
- •A. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 X ULN or = 5 times in the presence of liver metastases.
- •B. Total serum bilirubin = 1.5 X ULN
- •C. Absolute neutrophil count (ANC) = 1500 cells/mm3
- •D. Platelet count = 100,000 cells/mm3
- •E. Serum creatinine levels = 1.5 X ULN and calculated (by Cockcroft-Gault formula) or measured creatinine clearance = 50 mL/min
- •8. Subjects must be at least 3 weeks from last chemotherapy. For all prior anticancer treatment including radiotherapy or targeted agents or hormonal therapy, a duration of more than 5 half-lives of the targeted/hormonal agents used must have elapsed and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria.
- •9. Subjects with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months following the last dose of study drug. Effective contraception includes methods such as oral contraceptives, double-barrier method (condom plus spermicide or diaphragm) or abstaining from sexual intercourse.
- •10. Subjects who sign an approved informed consent form for the study.
- •11. Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy according to institutional standards (guided visually or by computed tomography [CT] or ultrasound), paracentesis, or thoracentesis for tumor cells before therapy at screening, and post-treatment (Cycle 2 Day 8 before carboplatin dose) if this is clinically and safely feasible to do so. In addition, any subject who has a therapeutic paracentesis or thoracentesis while on study should have tumor cells collected for analysis as part of the study whenever possible.
- •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 39
排除标准
- •1. Subjects who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products; however, if the subject had a previous platinum hypersensitivity reaction, Investigator discretion may be used to enroll subjects who successfully undergo the institutional desensitization protocol.
- •2. Subjects who have received prior therapy with the hypomethylating agents azacitidine (Vidaza®) or decitabine (Dacogen®).
- •3. Subjects who are refractory to platinum treatment i.e., defined as having never responded to any prior platinum treatment.
- •4. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
- •5. Subjects with a life-threatening illness, medical condition or organ system dysfunction, or other reasons which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with or compromise the integrity of the study outcomes including incomplete recovery from the acute effects from any prior anti-neoplastic therapy.
- •6. Subject must not have received mouse antibodies within 28 days of treatment.
- •7. Subjects with abnormal left ventricular ejection fraction (<50%) on echocardiogram or multiple-gated acquisition scan (MUGA).
- •8. Subject with Grade 2 or greater neuropathy.
- •9. Subjects with known brain metastases.
- •10. Subjects with prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least three years.
- •11. Subject with known history of human immunodeficiency virus (HIV) or if known seropositive for hepatitis C virus (HCV) or hepatitis B virus (HBV).
研究者
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