advanced esophagial cancer
Conditions
Interventions
BKM120 is administered orally once daily in 28-days cycles.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven esophagus squamous cancer. 2) With inoperable, recurrence, or metastatic lesion. 3)Prior chemotherapy was discontinued according to disease progression, or an adverse event. 4)>= 20 years old. 5)ECOG Performance Status of 0-1, or 2. 6)With one or more measurable lesion (based on a RECIST guideline ver1.1.) 7)Prior chemotherapies meet the criteria as follows. 1.have a history of a fluorinated Pyrimidine agents. 2.have a history of a platinum Agents. 3.History of 2 or more regimens. 8)Adequate organ function. I.e. meet all criterions as follows. 1.Absolute neutrophil count >=1,500 /mm3 2.Hemoglobin >=9.0 g/dL 3.Platelet count >=100,000 /mm3 4.Total bilirubin <=1.2 mg/dL 5.AST<=40 IU/L or <=120 IU/L with liver metastasis. 6.ALT <=40 IU/L or <=120 IU/L with liver metastasis. 7.Serum creatinine male <=1.5mg/dL female<=1.0mg/dL 8.Blood sugar <=120 mg/dL 9.HbA1c<=6.5% 9)No blood transfusion within 14 days prior to enrollment. 10)AE related to prior chemotherapy, radiation therapy or surgery must be Grade <= 1 according to CTCAE. 11)Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. 12)Adequate oral intake. 13)Written informed consent. 14)Tumor tissue is available for a cancer-related somatic gene analysis.
Exclusion criteria
Exclusion criteria: 1)Prior chemotherapy within 3 weeks prior to enrollment. 2)Major Surgery or radiation therapy within 3 weeks prior to enrollment. 3)Other investigational drugs within 3 weeks prior to enrollment. 4)with the history of PI3K Inhibitor AKT Inhibitor or mTOR Inhibitor treatment. 5)With CNS metastasis. 6)Carcinomatous pleural effusion, or ascites, cardiac effusion with indication of invasive treatment. 7)Synchronous or asynchronous other cancer except carcinoma in situ or intramucosal carcinoma. 8)Any severe and / or uncontrolled medical conditions. 9)Interstitial pneumonia. 10)Positive HBs antigen,HCV antibodyor known positive HIV antibody test. 11)Chronic treatment with steroids or another immunosuppressive agent. 12)Chronic treatment with warfarin or coumarin derivatives. 13)Treatment with strong CYP3A inhibitor. 14)PHQ-9 questionnaire is 12 or more. 15)PHQ-9 No.9 concerning the possibility of suicide idea of the PHQ-9 questionnaire was answered, "1,2 or 3". 16)GAD-7 questionnaire is >=15 17)The major depressive episode, the bipolar disorder,and the obsessive compulsive disorder, schizophrenia, the unsuccessful suicide attempt, the thought of suicide or homicide are possessed or the past exists. 18)Anxiety is Gr 3 or more. 19)With mind abnormal conduction. Unstable angina Pericarditis Cardiac infarction Congestive heart failure Cardiomyopathy 20)LVFE is less than 50% 21)With abnormal cardiac conduction Serious Ventricular arrhythmias Supraventricular or tuberosity arrhythmia Abnormal cardiac conduction Other abnormal arrhythmia that uncontrolled with medicine 22)QT interval is extended, and administering the medicine to which the risk of inducing torusa-dodopoan has been received now. 23)Gastrointestinal functional disorder or digestive diseases with the possibility to influence the absorption remarkably are possessed. 24)Pt is unwilling or unable to comply with the protocol. 25)Pt is judged by the investigator. 26)Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate: RR Progression free survival: PFS Overall survival : OS Adverse event : AE | — |
Countries
Japan
Contacts
Public ContactTakashi Kozima
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed