Phase 2 study of BKM120 in patients with advanced esophagus cancer

Phase 2

• Conditions: advanced esophagial cancer

• Registration Number: JPRN-UMIN000011217
• Lead Sponsor: ational Cancer Center Hospital East

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-31
• Study Completion: 2017-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified