Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum-resistant Ovarian Cancer (CORAIL Trial) - CORAIL Trial

Pharma Mar, S.A.0 个研究点目标入组 442 人开始时间: 2015年4月21日最近更新: 2019年1月7日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 442

研究概览入排标准研究者记录与标识符相似试验

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) Voluntary written informed consent (IC) of the patient obtained before any study-specific procedure.
•2) Age = 18 years.
•3) Histologically or cytologically confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
•4) Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).
•5) Radiologically measurable and/or non-measurable progressive disease according to RECIST v 1.1.
•6) No more than three prior systemic chemotherapy regimens. Note: in case that a patient had started a new systemic chemotherapy without disease progression to the prior chemotherapy line (e.g., treatment discontinuations due to toxicity; neoadjuvant followed by adjuvant chemotherapy regimens), these two chemotherapy regimens will considered as one.
•7) ECOG PS = 2.
•8) Adequate hematological, renal, metabolic and hepatic function:
•a) Hemoglobin = 9 g/dl [patients may have received prior red blood cell (RBC) transfusion]; absolute neutrophil count (ANC) = 2.0 x 109/l, and platelet count = 100 x 109/l.
•b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.0 x upper limit of normal (ULN).
•c) Alkaline phosphatase (AP) < 5.0 x ULN.
•d) Total bilirubin = ULN or direct bilirubin = ULN if total bilirubin is > ULN.
•e) Albumin = 3.0 g/dl.
•f) Calculated creatinine clearance (CrCL) = 30 ml/min (using Cockcroft and Gault's formula).
•g) Creatine phosphokinase (CPK) = 2.5 x ULN.
•9) At least three weeks since last prior therapy, and grade = 1 from any adverse event (AE) derived from previous treatment (excluding grade = 2 alopecia or peripheral neuropathy) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v. 4).
•10) Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry. A medically acceptable method of contraception must be maintained throughout the treatment period and for at least six months after treatment discontinuation.
•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 294
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 126

排除标准

•1) Concomitant diseases/conditions:
•a) History of cardiac disease: myocardial infarction or symptomatic/uncontrolled angina within the year prior to enrollment; or congestive heart failure defined as abnormal left ventricular ejection fraction (LVEF) < 50% assessed by multiple-gated acquisition scan (MUGA) or equivalent by ultrasound (US); or symptomatic arrhythmia.
•b) Patients with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV).
•c) Chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.
•d) Active uncontrolled infection.
•e) Bowel obstruction.
•f) Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization.
•g) Limitation of the patient's ability to comply with the treatment or to follow-up the protocol.
•h) Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
•2) Platinum-refractory or platinum-sensitive disease (PFI <1 or > 6 months).
•3) Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.
•Note: if 60% of recruitment is reached in one of the control treatment options (i.e., PLD or topotecan), patients could only be eligible if they did not previously receive the other control treatment option available (the Sponsor will inform the sites, if this occurs).
•4) Known brain metastases or leptomeningeal disease involvement.
•5) History of another neoplastic disease (except for curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or properly treated carcinoma in situ of the uterine cervix or breast) within three years prior to randomization.
•6) Pregnant or breast feeding women.

研究者

发起方

Pharma Mar, S.A.

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