EUCTR2015-004472-30-IT进行中（未招募）1 期
Randomized phase III trial on Trabectedin (ET-743) vs clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients - MITO 23
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 244
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
- •1. Female of age 18 years or older
- •2. Histologicallyorcytologically documentedinvasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- •3. Platinum resistant or sensitive patients with either:
- •a. BRCA mutated patients
- •b. BRCAness phenotype: patients who have received and responded (subsequent PFI>6 months) to at least 2 previous platinum based chemotherapy lines
- •c. Platinum sensitive patients who are not able to receive or not willing to receive other platinum treatments
- •4. Measurable and evaluable disease per RECIST 1.1(Subjects with isolated rising CA-125 without radiologically visible disease areexcluded)
- •5. ECOG performance status 0 or 1
- •6. No limitsinthenumber of previous chemotherapy lines,previous treatment with parp inhibitors is allowed
- •7.Left Ventricular Ejection Fraction (LVEF) =institutional lower limit normal
- •8. Life expectancy of at least 3 months
- •9.Adequate organ functions:
- •a. Hematopoietic; Absolute neutrophil count = 1,500/mm3
- •b. Platelet count = 100,000/mm3; Hemoglobin = 9 g/dl
- •c. Hepatic; AST and ALT = 1.5 times upper limit of normal (ULN)* ; Alkaline Phosphatase = 2.5 times ULN*; Bilirubin= 1.5 times ULN NOTE: * = 3 times ULN if liver metastases are present
- •d. Renal; Creatinine Clearance = 45 ml/min or Serum Creatinine =1.5 x ULN
- •e. Serum Albumin >2.5 g/dl
- •10. No other invasive malignancy within the past 3 years except non-melanoma skin cancer or in situ cervical cancer (patients with previouscancersmay be enrolled providing that no recurrenceshave be reported in the last 3 years)
- •11. Written Informed Consent
- •12. Adequately recovered from the acute toxicity of any prior treatment
- •13.For agents in the standard arm, also refer to the local prescribing information with regards to warnings, precautions, and contraindications
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1. Prior exposure to trabectedin
- •2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
- •3. Subjects with borderline ovarian cancer, ie. Subject with low malignant potential tumors are excluded
- •4. Less than 2 reported responses to platinum (i.e. subsequent recurrences at least 6 months after the first and the second platinum based
- •treatment), unless BRCA mutation is documented.
- •5. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
- •6. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3
- •years or longer
- •7. Known clinically relevant CNS metastases, unless treated and asymptomatic
- •8. Other serious illnesses, such as:
- •a.Congestiveheartfailureorangina pectoris,myocardialinfarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias.
- •b.Psychiatric disorder that prevents compliance with protocol.
- •c.Active viral hepatitis; or chronic liver disease.
- •d.Active infection.
- •e. Any other unstable medical conditions.
研究者
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