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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024333
Receipt No. R000028019
Scientific Title Phase 2 study of 2nd line dose-escalated nab-Paclitaxel for advanced or recurrent gastric cancer (KGSG1301)
Date of disclosure of the study information 2016/10/07
Last modified on 2017/05/29

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Basic information
Public title Phase 2 study of 2nd line dose-escalated nab-Paclitaxel for advanced or recurrent gastric cancer (KGSG1301)
Acronym Phase 2 study of 2nd line dose-escalated nab-Paclitaxel
Scientific Title Phase 2 study of 2nd line dose-escalated nab-Paclitaxel for advanced or recurrent gastric cancer (KGSG1301)
Scientific Title:Acronym Phase 2 study of 2nd line dose-escalated nab-Paclitaxel
Region
Japan

Condition
Condition Advanced or recurrent gastric cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of dose-escalated tri-weekly nab-Paclitaxel for pretreated stage 4 advanced or recurrent gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Adversed Event
Response Rate
Overall Survival
Time to Treatment Failure
Relative Dose Intensity

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 In the 1st course, ABI is administered 180mg/m2 intravenously for 30 minutes on day 1 of 3-week period.
In the 2nd and 3rd course, dose of ABI is modified by the frequency and severity of neutropenia.
3rd course onward, dose of ABI is not increased.
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 confirmed gastric cancer (adenocarcinoma)
2) Stage IV with evaluable lesion
3) Age of 20 years or older
4) Performance status: 0-1
5) Received Standard treatment as 1st line therapy (containing recurrent within 6 months after adjuvant chemotherapy)
6) Not received treatment (chemotherapy, immunotherapy, or radiation therapy) other than 5)
7) Adequate organ function
8) Expected survival period of more than 3 months
10) Written informed consent to participate
Key exclusion criteria 1) Severe bone marrow suppression
2) Complicated by infection
3) History of hypersensitivity to ABI, PAC or albumin
4) History of serious hypersensitivity
5) Pregnant or nursing woman
6) Significant abnormal electrocardiogram or heart disease to be clinically relevant
7) Pleural effusion or ascites in need of treatment
8) Brain metastases
9) Active double cancer (synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years; carcinoma in situ judged to be cured by local treatment are not considered to be active double cancers)
10) Peripheral neuropathy which were graded 2 or higher
11) Interstitial pneumonia or pulmonary fibrosis
12) HBs antigen or HCV antibody positive
13) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo BABA
Organization Graduate School of Medical Science, Kumamoto University
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1-1, Honjo Chuo-ku, Kumamoto
TEL 096-373-5212
Email hdobaba@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki IWATSUKI
Organization Graduate School of Medical Science, Kumamoto University
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1-1, Honjo Chuo-ku, Kumamoto
TEL 096-373-5212
Homepage URL
Email maiwa217@kumamoto-u.ac.jp

Sponsor
Institute Graduate School of Medical Science, Kumamoto Universit
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 10 Month 07 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 07 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 31 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
2016 Year 10 Month 07 Day
Last modified on
2017 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028019

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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