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临床试验/EUCTR2014-001921-34-BE
EUCTR2014-001921-34-BE进行中（未招募）1 期

A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant

Millennium Pharmaceuticals, Inc.0 个研究点目标入组 128 人开始时间: 2014年11月19日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
128
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. Advanced or metastatic breast cancer.
  • •2. Histological or cytological confirmation of ER+ status (defined as > 1% positive tumor cells), and histological or cytological confirmation of HER2-negative (HER2-) status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.
  • •3. Female patients 18 years of age or older who:
  • •- Are postmenopausal for at least 1 year before the Screening visit, where menopause is defined by:
  • •o Age = 55 years and 1 year or more of amenorrhea
  • •o Age < 55 years and 1 year or more of amenorrhea, with an estradiol assay < 20 pg/mL
  • •o Surgical menopause with bilateral oophorectomy
  • •4. Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:
  • •- Brain metastases which have been treated
  • •- No evidence of disease progression for ? 3 months or hemorrhage after treatment
  • •- Off-treatment with dexamethasone for 4 weeks before administration of the first dose of MLN0128
  • •- No ongoing requirement for dexamethasone or anti-epileptic drugs
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 as defined in the protocol
  • •6. Clinical laboratory values as specified below within 4 weeks before the first dose of MLN0128:
  • •- Bone marrow reserve consistent with absolute neutrophil count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/L; hemoglobin = 9 g/dL
  • •- Total bilirubin = 1.5 x the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (= 5 xULN if liver metastases are present)
  • •- Creatinine clearance = 50 mL/min based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection
  • •- Fasting serum glucose = 130 mg/dL and fasting triglycerides = 300 mg/dL
  • •7. Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of institutional standard of normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks before the first dose of MLN0128 (ie, if the institutional standard of normal is 50%, LVEF may be as low as 45% to be eligible for the study).
  • •8. Able to provide paraffin blocks or a minimum of 10 unstained slides of available archival tumor tissues (paraffin blocks are preferred). If archival tumor tissue is not available, a tumor biopsy may be performed before the patient begins treatment with MLN0128. If fewer than 10 slides are available or the tumor content/area
  • •requirements are not met, study eligibility will be determined upon discussion with the sponsor.
  • •9. Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.
  • •10. Voluntary written consent must be given before the performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  • •Phase 1b Only:
  • •11. Patients may have SD or disease progression during their most recent treatment with exemestane or fulvestrant, or everolimus in combination with either exemestane (any country) or fulvestrant (US Only). Exemestane or fulvestrant in combination with MLN0128 can also be initiated as a new line of therapy.
  • •Phase 2 Only
  • •12. Measureable disease defined as follows:
  • •- At least 1 extra-osseous lesi

排除标准

  • •1. Prior anticancer therapy or other investigational therapy within 2 weeks before administration of the first dose of MLN0128 (except for exemestane or fulvestrant, which should be continued). Treatment with everolimus must be discontinued 2 weeks before administration of the first dose of MLN0128.
  • •2. Chronic concomitant therapy with bisphosphonates or denosumab for the prevention of bone metastases. Concomitant treatment with bisphosphonates is permitted for treatment of osteoporosis or management of existing bone metastases if initiated at least 4 weeks before administration of the first dose of MLN0128.
  • •3. Exclusion criterion 3 was removed as of Protocol Amendment 6.
  • •4. Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of MLN0128 (patients already receiving erythropoietin on a chronic basis for = 4 weeks are eligible).
  • •5. Previous treatment with dual PI3K/mTOR inhibitors or TORC1/2 inhibitors.
  • •6. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128.
  • •7. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met.
  • •8. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study.
  • •9. Known human immunodeficiency virus infection.
  • •10. History of any of the following within the last 6 months before administration of the first dose of MLN0128:
  • •- Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
  • •- Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures
  • •- Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia)
  • •- Placement of a pacemaker for control of rhythm
  • •- New York Heart Association Class III or IV heart failure
  • •- Pulmonary embolism
  • •11. Significant active cardiovascular or pulmonary disease before administration of the first dose of MLN0128, including:
  • •- Uncontrolled hypertension (ie, systolic blood pressure > 180 mm Hg; diastolic blood pressure > 95 mm Hg)
  • •- Pulmonary hypertension
  • •-Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air
  • •- Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement
  • •- Medically significant (symptomatic) bradycardia
  • •- History of arrhythmia requiring an implantable cardiac defibrillator
  • •- Baseline prolongation of the rate-corrected QT interval (QTc; eg, repeated demonstration of QTc interval > 480 ms, or history of congenital long QT syndrome, or torsades de pointes)
  • •12. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of MLN0128 or previously diagnosed with another malignancy and have

研究者

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