EUCTR2015-002395-24-BE进行中（未招募）1 期
Phase II, Open-Label, Randomized, Controlled Study of PM060184 in Advanced, Hormone Receptor Positive, HER2 negative Breast Cancer Patients in Third or Fourth Line Setting.
Pharma Mar, S.A.0 个研究点目标入组 106 人开始时间: 2016年5月11日最近更新:
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
- 106
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) Voluntarily written informed consent (IC), obtained from the patient before the beginning of any specific study procedures.
- •2) Age = 18 years.
- •3) Histologically proven diagnosis of breast cancer.
- •4) Tumors must be hormone receptor (ER and/or PgR) positive and
- •HER2 negative.
- •5) Two or three chemotherapy lines in the advanced setting (adjuvant and/or neoadjuvant chemotherapy are allowed).
- •6) Previous treatment with anthracyclines and taxanes (unless clinically contraindicated for any of them).
- •7) Disease progression should have occurred within 2 months before study entry and within 6 months of the last administration of chemotherapy for advanced disease.
- •8) Measurable disease as defined by the RECIST criteria 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 of the lesion must be demonstrated.
- •9) Patients with dermic metastatic pattern only: lesions should have at least 10 mm diameter assessed by calipers and should be documented by color photography including a ruler to estimate the size of the lesion.
- •10) Patients with bone metastases will be eligible if other sites of
- •measurable disease are present.
- •11) Eastern Cooperative Oncology Group (ECOG) performance status
- •(PS) 0 or 1.
- •12) For patients in both arms, adequate bone marrow, liver and kidney
- •a) Hemoglobin = 9 g/dl.
- •b) Neutrophil count = 1.5 × 109/l.
- •c) Platelet count = 100 × 109/l.
- •d) Serum creatinine = 1.5 mg/dl or calculated creatinine clearance = 40
- •e) Albumin = 2.5 g/dl.
- •f) Total serum bilirubin = 1.5 x upper limit of normal (ULN), except in
- •case of Gilbert´s syndrome.
- •g) Alanine aminotransferase (ALT) and aspartate aminotransferase
- •(AST) = 3 × ULN (= 5.0 x ULN in the presence of liver metastases).
- •13) Peripheral neuropathy grade = 1 according to the National Cancer
- •Institute Common Terminology Criteria for the Classification of Adverse
- •Events (NCI-CTCAE) (v.4).
- •14) Complete recovery to grade = 1 from any toxicity due to a previous
- •therapy (except for alopecia) according to the NCI-CTCAE (v.4) criteria.
- •15) Left ventricular ejection fraction (LVEF) by echocardiography (ECHO)
- •or multiple-gated acquisition (MUGA) scan within normal range
- •(according to institutional standards).
- •16) At least three weeks since the last administration of chemotherapy,
- •biological therapy or investigational drug; six weeks since the last
- •administration of nitrosoureas and mitomycin C, and one week since the
- •last dose of hormone-therapy.
- •17) At least three weeks since the end of radiotherapy involving up to
- •35% of the bone marrow (radiotherapy involving > 35% of bone
- •marrow is not allowed) or two weeks since the end of palliative
- •radiotherapy, including single doses.
- •18) Life expectancy = 3 months.
- •19) Women of child-bearing potential must have a negative pregnancy
- •test seven days prior to treatment administration; a medically approved
- •method of contraception must be maintained while on treatment with
- •any of the trial medications and for six months after their last
- •administration. Peri-menopausal women must have had amenorrhea for
- •at least 12 months to be considered of non-childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •1) Prior exposure to PM060184.
- •2) Concomitant administration of any other antineoplastic therapy.
- •3) History of another neoplastic disease (except for prior breast cancer,
- •basal cell carcinoma of the skin, properly treated in situ carcinoma of
- •the uterine cervix, or melanoma in situ), unless in remission for five
- •years or longer and without local or systemic recurrence.
- •4) Presence of cerebral and/or leptomeningeal metastasis, even if they
- •are being treated.
- •5) Patients with locally advanced disease amenable to local therapy at
- •study entry.
- •6) Unknown HR status (both ER and PgR) and HER2 new status.
- •7) Inflammatory breast carcinoma.
- •8) Other serious and/or relevant diseases or clinical situations that, in
- •the Investigator´s opinion, are incompatible with the protocol (any of
- •the following):
- •a) History of cardiac disease, such as myocardial infarction, in the year
- •prior to enrollment in the clinical trial; symptomatic/uncontrolled angina
- •pectoris; congestive heart failure or uncontrolled cardiac ischemia; any
- •type of uncontrolled arrhythmia or abnormal left ventricular ejection
- •fraction, or uncontrolled arterial hypertension (according to the
- •standards of the World Health Organization, WHO).
- •b) History of significant psychiatric disease.
- •c) Active infection requiring antibiotic, antifungal or antiviral treatment
- •that, in the opinion of the Investigator, could compromise the patient´s
- •capacity to tolerate the therapy.
- •d) Known active liver (hepatitis B or C or cirrhosis) or renal disease.
- •e) Known human immunodeficiency virus (HIV) infection.
- •f) Major surgery within the two weeks prior to entering the clinical trial
- •or any other concomitant pathology that could jeopardize the patient´s
- •safety or commitment to complete the clinical trial.
- •9) Pregnant or breastfeeding women.
- •10) Inability or refusal to comply with the protocol or with the clinical
- •trial procedures.
- •11) Known hypersensitivity to PM060184 or any of the drugs to be used
- •in the PSPC arm (second stage).
研究者
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