CTRI/2010/091/001281已完成2 期
Phase II single-arm study of ON 01910.Na BY 4 HOUR INFUSION in patients with recurring platinum-resistant ovarian cancer - Nil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Women with ovarian cancer aged greater than or equal to 18 yeras to les than or equal to 65 years with measurable disease who have shown recurrent disease within 6 months of the last dose of cisplatin- or carboplatin-based chemotherapy.
- •a. Measurable disease will be defined as lesions that can be accurately measured in at least one dimension with longest diameter greater than or equal to 20 mm using conventional techniques or gretaer than or equal to 10 mm with spiral CT scan.
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 (see Attachment 1 of Protocol).
- •3. No more than 3 prior chemotherapy regimens.
- •4. Disease-free period of more than 5 years from prior malignancies other than ovarian (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix).
- •5. All patients of childbearing potential must use at least one form of contraception as approved by the Investigator prior to study and up to 30 days beyond the last administration of study drug.
- •6. Women of childbearing potential must have a negative serum betaHCG pregnancy test at screening.
- •7. Willing to adhere to the prohibitions and restrictions specified in this protocol.
- •8. Patient (or her legally authorized representative) must have signed an informed consent document
排除标准
- •1. Evidence of complete or partial bowel obstruction.
- •2. Need for IV hydration or Total Parenteral Nutrition.
- •3. Inability to comply with study and/or follow-up procedures.
- •4. Life expectancy of less than 12 weeks.
- •5. Prior radiotherapy to greater than one third of hematopoietic sites.
- •6. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- •7. Active infection not adequately responding to appropriate therapy.
- •8. Hyponatremia (defined as serum sodium value of 134 mEq/L)
- •9. Total bilirubin greater than or equal to 1.5 mg/dL not related to hemolysis or Gilbert?s disease, AST/ALT or alkaline phosphatase greater than or equal to 2 X upper limit of normal (ULN).
- •10. Serum creatinine greater than or equal to 2.0 mg/dL.
- •11. ANC 1500/mm3, platelets 100,000/mm3; hemoglobin less than 9 g/dL.
- •12. Ascites requiring active medical management including paracentesis for more than twice a month.
- •13. Women patients who are pregnant or lactating or have a positive serum betaHCG pregnancy test at screening.
- •14. Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
- •15. Uncontrolled hypertension (defined as a systolic pressure greater than or equal to 160 and/or a diastolic pressure greater than or equal to 110).
- •16. New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures.
- •17. Brain metastases including any of the following:
- •a. Evidence of cerebral edema by CT scan or MRI
- •b. Evidence of disease progression on prior imaging studies
- •c. Requirement for steroids
- •d. Clinical symptoms of brain metastases
- •18. Any concurrent, and/or within 4 weeks of the first dose of study drug, investigational agent or chemotherapy, radiotherapy or immunotherapy
- •19. Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements
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