A Phase II, Open-label, Multicenter Study of PM060184 in Patients with Advanced Colorectal Cancer after Standard Treatment

Pharma Mar, S.A.0 个研究点目标入组 60 人开始时间: 2017年12月1日最近更新: 2019年2月28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: 60

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

入选标准

•1) Voluntarily written informed consent, obtained before the
•beginning of any study-specific procedures.
•2) Age > or = 18 years.
•3) Histologically-cytologically documented adenocarcinoma of
•colon or rectum that has progressed to the last prior treatment
•before inclusion.
•4) Measurable disease according to Response Evaluation Criteria
•in Solid Tumors (RECIST) v.1.1. If the only tumor lesion is situated in a previously irradiated area or in an area subjected
•to other loco-regional therapy, progression in the lesion must
•be demonstrated radiologically.
•5) Previous treatment in any setting with fluoropyrimidine,
•oxaliplatin and irinotecan in any combination (unless any is
•contraindicated).
•a) Adjuvant chemotherapy-based treatments count as prior
•therapy, as long as relapse had occurred during or within
•six months of completion of such therapies.
•b) Cumulative dose of prior oxaliplatin (if any) must be
•c) Prior cetuximab, panitumumab, bevacizumab, aflibercept,
•and regorafenib are allowed.
•6) No more than two prior therapies for metastatic disease.
•7) Washout periods for prior therapies (defined in relation to
•planned start of study treatment [first dose administration]):
•a) At least three weeks since the last administration of an
•antineoplastic treatment (chemotherapy, biological,
•targeted or investigational therapies).
•b) At least three weeks since radiotherapy involving up to
•35% of bone marrow (radiotherapy involving > 35% of
•bone marrow is not allowed) or two weeks since the end
•of palliative radiotherapy including single doses.
•c) At least four weeks since any major surgical procedure,
•open biopsy, or significant traumatic injury.
•8) Eastern Cooperative Oncology Group (ECOG) performance
•status (PS) 0 or 1.
•9) Life expectancy > or = 3 months.
•10)Adequate bone marrow, liver, and kidney function:
•a) Hemoglobin > or = 9 g/dL.
•b) Absolute neutrophil count > or =1.5 × 10 9/L.
•c) Platelet count > or = 100 × 10 9/L.
•d) Serum creatinine < or = 1.5 mg/dL or calculated creatinine
•clearance > or = 40 mL/min (Cockcroft-Gault formula).
•e) Albumin > or = 2.5 g/dL.
•f) Total serum bilirubin < or = 1.5 times the upper limit of normal
•(ULN), except in case of Gilbert syndrome.
•g) Alanine aminotransferase (ALT) and aspartate
•aminotransferase (AST) < or = 3 × ULN (< or = 5.0 × ULN in the
•case of liver metastases).
•11)Recovery to grade < or = 1 from any toxicity due to previous
•therapy (including peripheral sensory/motor neuropathy but
•excluding alopecia).
•12)Left ventricular ejection fraction (LVEF) by echocardiography
另有 2 项未显示

排除标准

•1) Prior exposure to PM060184.
•2) Known hypersensitivity to the study drug class or study drug
•excipient in the formulation.
•3) Patients with locally advanced disease amenable to local
•and/or curative therapy (surgery or radiotherapy) at study
•4) Other serious and/or relevant diseases or clinical situations
•that, in the opinion of the Investigator, are incompatible with
•the protocol (including any of the following):
•a) History of another neoplastic disease (except for basal cell
•carcinoma of the skin, superficial bladder tumors, or
•properly treated carcinoma in situ of the uterine cervix or
•melanoma in situ) unless in remission for at least five
•years and with no recurrence.
•b) Symptomatic cerebral and/or leptomeningeal metastasis,
•spinal cord compression or carcinomatous meningitis.
•c) Neuropathy of any etiology (other than that caused by
•previous antineoplastic therapy).
•d) History of cardiac disease, such as myocardial infarction,
•in the year prior to registration in the clinical trial;
•symptomatic/uncontrolled angina pectoris; congestive
•heart failure or uncontrolled cardiac ischemia; any type of
•uncontrolled arrhythmia, congenital and/or prolonged QT
•interval or abnormal LVEF, or uncontrolled arterial
•hypertension (according to the standards of the World
•Health Organization [WHO]).
•e) History of significant psychiatric disease.
•f) Active infection requiring antibiotic, antifungal or
•antiviral treatment that, in the opinion of the Investigator,
•could compromise the patient’s capacity to tolerate the
•g) Known active liver (hepatitis B or C or cirrhosis) or renal
•h) Known human immunodeficiency virus (HIV) infection.
•i) Any other concomitant pathology that could jeopardize
•the patient’s safety or commitment to complete the
•clinical trial.
•j) Inability or refusal to comply with the protocol or with the
•clinical trial procedures.
•5) Pregnancy or lactation.

研究者

发起方

Pharma Mar, S.A.

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