NCT01806649终止2 期
A Phase II Study of BKM120; a Pan-PI3K Inhibitor in Patients With Esophageal Squamous Cell Carcinoma After Failure of First Line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- disease control rate
研究概览
简要总结
There is a need for more effective therapy for patients with esophageal squamous cell carcinoma who developed disease progression after first line therapy. Currently, there is no standard second-line therapy for this disease.
BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. In a cellular model of oral-esophageal carcinogenesis, it has shown that EGFR overexpression activated PI3/AKT pathway. Therfore, there is interest to see the efficacy and safety of BKM120 in this setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure.
- •Age ≥ 18 years old
- •Histologically confirmed diagnosis of esophageal squamous cell carcinoma and available archival tissue for evaluation of further studies.
- •Metastatic or unresectable disease
- •Received one prior chemotherapy or biological therapy regimen for unresectable or metastatic disease
- •More than 30 days since prior chemotherapy, surgery, radiotherapy, or investigational agents
- •Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
- •No evidence of brain metastasis
- •Patient has adequate bone marrow and organ function
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Hemoglobin ≥ 9.0 g/dL
- •Potassium, calcium, magnesium within normal limits for the institution
- •Serum Creatinine ≤ 1.5 x ULN or Creatinine clearance > 60 mL
- •AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
- •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 serum glucose < 1.5 times ULN
排除标准
- •Patient has received previous treatment with PI3K inhibitors
- •Patient has symptomatic CNS metastases
- •Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases > 28 days (including radiotherapy and/or surgery) prior to enrollment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- •Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ.
- •Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist, 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 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of 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 (immediate risk of doing harm to others) ≥ CTCAE grade 3 anxiety
- •Patient is concurrently using other approved or investigational antineoplastic agent
- •Patient has had major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery
- •Patient has poorly controlled diabetes mellitus(HbA1c > 8 %)
- •Patient has active cardiac disease including any of the following:
- •LVEF < 50%
- •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
- •Conduction abnormality requiring a pacemaker
- •Valvular disease with documented compromise in cardiac function
- •Symptomatic pericarditis
- •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 (New York Heart Association functional classification III-IV)
- •Documented cardiomyopathy
- •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
- •Inability to swallow, impaired gastrointestinal (GI) function, or GI disease that would significantly alter the absorption of study drugs or preclude the use of oral medications
- •Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g.,chronic pancreatitis, active chronic hepatitis etc.)
- •Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
研究组 & 干预措施
BKM120
Experimental
BKM120, starting at 100 mg oral once daily
干预措施: BKM120 (Drug)
结局指标
主要结局
disease control rate
时间窗: 16 weeks
16-week disease control rate using RECIST 1.1 criteria
次要结局
- safety(each follow up visit, assessed up to 12 months)
- overall survival(Time from day 1 to date of death, assessed up to 18 months)
- progression-free survival(Time from day 1 to date of documented disease progression or death, assessed up to 12 months)
研究者
Arunee Dechaphunkul
Dr
Prince of Songkla University
研究点 (1)
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