UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011672
Receipt number R000013649
Scientific Title Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer
Date of disclosure of the study information 2013/09/06
Last modified on 2013/09/06 18:50:59

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Basic information

Public title

Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer

Acronym

Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer

Scientific Title

Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer

Scientific Title:Acronym

Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy and safety of abraxane and trastuzumab in patients with advanced/recurrent HER2-positive gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

clinical benefit

Key secondary outcomes

sefety


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

Administration of abraxane with a dose of 260 mg/m2 for days1 of 21 day course. Administration of trastuzumab every 3 weeks with a starting dose of 8 mg/kg followed by 6 mg/kg as the second and subsequent doses.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. persons with gastric cancer which is confirmed to be invasive gastric cancer by histological or cytological examination.
2. Advanced/reccurent HER2-positive gastric cancer .
3. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
4. Patients with a performance status (ECOG) of 0, 1, or 2
5. Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan).
6. Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration.
(1)Neutrophil>=1,500/mm3
(2)Platelet>=100,000/mm3
(3)Hb>=9.0g/dL
(4)T-BIL<=2.0mg/dL
(5)AST, ALT <=100IU/L
(6)Serum creatinine <= 1.5mg/dL
7. Patients expected to survive for 6 months or more.
8. Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec).
9. Patients who provided written informed consent by themselves in principle to participate in this trial.

Key exclusion criteria

1. Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer.
2. Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema.
3. Patients with brain metastases treatment is required at the time of registration.
4. Patients with serious co-morbidities
(1)Uncontrolled diabates
(2)Uncontrolled hypertension
(3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication.
(4)Ischemic heart disease, arrhythmias, valvular disease requiring medication.
(5)Liver dysfunction(jaundice)
(6)Renal dysfunction
(7)Active infection or fever suspicious of infection.
(8)Other serious complications
5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuji Takayama

Organization

The University of Tokushima graduate school

Division name

gastroenteroloy and oncology

Zip code


Address

15-18-3 Kuramoto-cho Tokushima-city Tokushima Japan

TEL

088-633-7142

Email

takayama@md.pikara.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kanako Otsuka

Organization

The University of Tokushima graduate school

Division name

gastroenteroloy and oncology

Zip code


Address

15-18-3 Kuramoto-cho Tokushima-city Tokushima Japan

TEL

088-633-7142

Homepage URL


Email

falko326@hotmail.co.jp


Sponsor or person

Institute

The University of Tokushima graduate school

Institute

Department

Personal name



Funding Source

Organization

The University of Tokushima graduate school

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 06 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

Preinitiation

Date of protocol fixation

2003 Year 09 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 06 Day

Last modified on

2013 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013649


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name