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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011217
Receipt No. 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

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Basic information
Public title Phase 2 study of BKM120 in patients with advanced esophagus cancer
Acronym BKM120 Phase 2 ESCC
Scientific Title Phase 2 study of BKM120 in patients with advanced esophagus cancer
Scientific Title:Acronym BKM120 Phase 2 ESCC
Region
Japan

Condition
Condition advanced esophagial cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of BKM120 in patients with advanced esophagus cancer which refractory to pre-chemotherpy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate (DCR)
Key secondary outcomes Response rate: RR
Progression free survival: PFS
Overall survival : OS
Adverse event : AE

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BKM120 is administered orally once daily in 28-days cycles.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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
Target sample size 41

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Doi
Organization National Cancer Center Hospital East
Division name Department of Experimental Therapeutics,
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email bkm_core@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kozima
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email bkm_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Novartis Pharmaceuticals
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 31 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 18 Day
Last modified on
2017 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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