UMIN-CTR Clinical Trial

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

Advanced or recurrent gastric cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Progression Free Survival

Key secondary outcomes

Adversed Event
Response Rate
Overall Survival
Time to Treatment Failure
Relative Dose Intensity

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medical Science, Kumamoto Universit

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

10

Month

07

Day

Last modified on

2017

Year

05

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028019