EUCTR2014-003773-42-BE进行中（未招募）1 期
A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors. - N.A.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 325
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
- All
入选标准
- •1) Age = 18 years.
- •2) Voluntary signed informed consent (IC) of the patient
- •before any study-specific procedure.
- •3) Pathologically proven diagnosis of any of the following
- •malignancies:
- •a) Small cell lung cancer (SCLC).
- •b) Head and neck carcinoma (H&N). Salivary glands
- •tumors are excluded.
- •c) Neuroendocrine tumors (NETs), grade 2 and grade 3
- •according to World Health Organization (WHO)
- •classification.
- •d) Biliary tract carcinoma.
- •e) Endometrial carcinoma.
- •f) BRCA 1/2- associated metastatic breast carcinoma
- •g) Carcinoma of unknown primary site.
- •h) Germ cell tumor (GCTs), excluding immature teratoma,
- •or teratoma with malignant transformation.
- •i) Ewing’s family of tumors (EFTs).
- •4) Prior treatment. Patients must have received:
- •a) SCLC: one prior chemotherapy-containing line.
- •b) H&N: one or two prior chemotherapy-containing lines.
- •c) NETs: one or two prior chemotherapy-containing lines.
- •No more than three prior hormone or biological therapy
- •d) Biliary tract carcinoma: one or two prior chemotherapy containing lines.
- •e) Endometrial carcinoma: one prior chemotherapycontaining line.
- •f) BRCA 1/2-associated metastatic breast carcinoma: at east one but no more than three prior chemotherapy -containing lines.
- •g) Carcinoma of unknown primary site: one or two prior
- •chemotherapy-containing lines.
- •h) GCTs: no limit of prior therapy (patients with no other
- •clinical therapeutic options).
- •i) EFTs: no more than two prior chemotherapy-containing
- •lines in the metastatic/recurrent setting.
- •5) Measurable disease as defined by RECIST v.1.1, and
- •documented progression before study entry.
- •6) Eastern Cooperative Oncology Group (ECOG)
- •performance status (PS) = 2.
- •7) Adequate major organ function:
- •a) Hemoglobin = 9 g/dl, prior red blood cell (RBC)
- •transfusions are allowed if clinically indicated; 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
- •c) Total bilirubin = 1.5 x ULN, or direct bilirubin = ULN.
- •d) Albumin = 3 g/dl.
- •e) Serum creatinine = 1.5 x ULN or creatinine clearance =
- •f) Creatine phosphokinase (CPK) = 2.5 x ULN.
- •8) Washout periods prior to Day 1 of Cycle 1:
- •a) At least three weeks since the last chemotherapy (six
- •weeks if therapy contained nitrosureas or systemic
- 另有 22 项未显示
排除标准
- •1) Prior treatment with PM01183 or trabectedin.
- •2) Prior or concurrent malignant disease unless in complete
- •remission for more than five years, except treated in situ
- •carcinoma of the cervix, basal or squamous cell skin
- •carcinoma, and in situ transitional cell bladder carcinoma.
- •3) Known central nervous system (CNS) involvement. In
- •patients with SCLC, brain computed tomography (CT)-scan
- •or magnetic resonance imaging (MRI) results must be
- •provided at baseline.
- •4) Relevant diseases or clinical situations which may increase
- •the patient’s risk:
- •a) History within the last year or presence of unstable
- •angina, myocardial infarction, congestive heart failure,
- •or clinically relevant valvular heart disease or
- •symptomatic arrhythmia or any asymptomatic
- •ventricular arrhythmia requiring ongoing treatment.
- •b) Grade = 3 dyspnea or daily intermittent oxygen
- •requirement within two weeks prior to the study
- •treatment onset.
- •c) Active infection.
- •d) Unhealed wounds or presence of any external drainage.
- •e) Known chronic active hepatitis or cirrhosis.
- •f) Immunocompromised patients, including known
- •infection by human immunodeficiency virus (HIV).
- •5) Women who are pregnant or breast-feeding, and fertile
- •patients (men and women) who are not using an effective
- •method of contraception. *
- •6) Impending need for RT (e.g., painful bone metastasis
- •and/or risk of spinal cord compression).
- •7) Limitation of the patient’s ability to comply with the
- •treatment or to follow-up the protocol.
- •* Women of childbearing potential (WOCBP) must agree to
- •use an effective contraception method to avoid pregnancy
- •during the course of the trial (and for at least three months after
- •the last infusion). Valid methods to determine the childbearing
- •potential, adequate contraception and requirements for WOCBP
- •partners are described in APPENDIX 2. Fertile men must agree
- •to refrain from fathering a child or donating sperm during the
- •trial and for four months after the last infusion.
研究者
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