UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of 2nd line dose-escalated nab-Paclitaxel for advanced or recurrent gastric cancer (KGSG1301)
Title of the study (Brief title)	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	Hideo BABA
Organization	Graduate School of Medical Science, Kumamoto University
Division name	Department of Gastroenterological Surgery
Address	1-1-1, Honjo Chuo-ku, Kumamoto
TEL	096-373-5212
Email	hdobaba@kumamoto-u.ac.jp

Public contact
Name of contact person	Masaaki IWATSUKI
Organization	Graduate School of Medical Science, Kumamoto University
Division name	Department of Gastroenterological Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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