EUCTR2011-006083-45-ES进行中（未招募）1 期
A phase II trial of BKM120 (a PI3K inhibitor) in patients with triple negative metastatic breast cancer - n.a
SOLTI (Grupo Español de Estudio, Tratamiento y Otras Estrategias Experimentales en Tumores Sólidos)0 个研究点目标入组 50 人开始时间: 2012年1月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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.The subject has pathologically and radiologically confirmed metastatic triple negative breast cancer (Stage IV disease), previously documented by histological analysis, which is ER-negative and PR-negative by immunohistochemistry (IHC) defined as ER and PR expression < 1% and HER2 negative by immunohistochemistry (IHC) or FISH/CISH. If patient has more than one histological result, the most recent one has to be considered for inclusion.
- •2.Subjects must have received at least two prior chemotherapy regimens in the adjuvant or metastatic setting.
- •3.Availability of a representative tumor specimen (primary or metastasis, archival or fresh) is mandatory at baseline for retrospective analysis of relevant molecular alterations ( e.g., PIK3CA, PTEN, Ras, etc).
- •4.At least one measurable lesion defined by RECIST 1.1
- •5.Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure.
- •6.Patient is ? 18 years at the day of consenting to the study
- •7.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 2
- •8.Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- •? Absolute Neutrophil Count (ANC) ? 1.0 x 109/L
- •? Platelets ? 100 x 109/L
- •? Hemoglobin ? 9.0 g/dL
- •? INR ? 2Potassium, calcium, magnesium within normal limits for the institution
- •? Serum Creatinine ? 1.5 x ULN
- •?Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range (or ? 3.0 x ULN if liver metastases are present)
- •?Serum bilirubin within normal range (or ? 1.5 x ULN if liver metastases are present; or total bilirubin ? 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
- •? Fasting plasma glucose (FPG) ? 120 mg/dL or ? 6.7 mmol/L
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Patient has received previous treatment with PI3K inhibitors.
- •2.Patient has symptomatic CNS metastases
- •3.Patients with controlled and asymptomatic CNS metastases may participate.The patient must have completed any prior treatment for CNS metastases > 28 days prior to enrollment. Patients with previously treated brain metastases on a stable low dose corticosteroids treatment are eligible
- •4.Patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer). An exception to this rule are patients with documented germline mutations in BRCA1 or 2, who may have previous history of cancer.
- •5.Patient has any of the following mood disorders, or meets the cut-off score of ? 10 in the PHQ-9 or a cut-off of ? 15 in the GAD-7 mood scale, respectively, or selects a positive response of ?1, 2, or 3? to question number 9 in the PHQ-9
- •?Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation
- •?? CTCAE grade 3 anxiety
- •6.Patient is concurrently using other approved or investigational antineoplastic agent
- •7.Patient has received radiotherapy ? 28 days prior to enrollment in this study or has not recovered from side effects of such therapy at the time of initiation of screening procedures.
- •8.Patient has had major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery
- •9.Patient has poorly controlled diabetes mellitus (HbA1c > 8 %)
- •10.Patient has active cardiac disease including any of the following:
- •?LVEF < 50% as determined by MUGA or ECHO
- •?QTc > 480 msec on screening ECG (using the QTcF formula)
- •?Angina pectoris that requires the use of anti-anginal medication
- •?Ventricular arrhythmias except for benign premature ventricular contractions
- •?Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication
- •?abnormality requiring a pacemaker
- •?Valvular disease with documented compromise in cardiac function
- •?Symptomatic pericarditis
- •11.Patient has a history of cardiac dysfunction including any of the following;
- •?Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
- •?History of documented congestive heart failure (NYHAclass III-IV)
- •?Documented cardiomyopathy
- •12.Patient is currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
- •13.Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
- •14.Patient receiving chronic treatment with steroids or another immunosuppressive agent. Note: Topical applications, inhaled sprays, eye drops or local injections are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g., dexamethasone 2 mg/day, prednisolone 10 mg/day) for at least 14 days before start of study treatment, are eligible.
- •15.Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator?s judgment contraindicate her participa
研究者
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