Unique ID issued by UMIN | UMIN000011217 |
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Receipt number | R000013066 |
Scientific Title | Phase 2 study of BKM120 in patients with advanced esophagus cancer |
Date of disclosure of the study information | 2013/07/31 |
Last modified on | 2017/03/16 13:18:51 |
Phase 2 study of BKM120 in patients with advanced esophagus cancer
BKM120 Phase 2 ESCC
Phase 2 study of BKM120 in patients with advanced esophagus cancer
BKM120 Phase 2 ESCC
Japan |
advanced esophagial cancer
Gastroenterology |
Malignancy
YES
To evaluate the efficacy and safety of BKM120 in patients with advanced esophagus cancer which refractory to pre-chemotherpy.
Efficacy
Exploratory
Phase II
Disease control rate (DCR)
Response rate: RR
Progression free survival: PFS
Overall survival : OS
Adverse event : AE
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
BKM120 is administered orally once daily in 28-days cycles.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
41
1st name | |
Middle name | |
Last name | Toshihiko Doi |
National Cancer Center Hospital East
Department of Experimental Therapeutics,
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
bkm_core@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Takashi Kozima |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
bkm_core@east.ncc.go.jp
National Cancer Center Hospital East
Novartis Pharmaceuticals
Profit organization
NO
国立研究開発法人国立がん研究センター中央病院(東京都)
国立研究開発法人国立がん研究センター東病院(千葉県)
独立行政法人四国がんセンター(愛媛県)
がん研究会有明病院(東京都)
埼玉県立がんセンター(埼玉)
愛知がんセンター中央病院(愛知県)
2013 | Year | 07 | Month | 31 | Day |
Unpublished
Terminated
2013 | Year | 05 | Month | 17 | Day |
2013 | Year | 07 | Month | 31 | Day |
2017 | Year | 03 | Month | 01 | Day |
2013 | Year | 07 | Month | 18 | Day |
2017 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013066
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