UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011217
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

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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 or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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

Value
https://center6.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