UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030277
Receipt number R000034583
Scientific Title Pharmacokinetic and Pharmacodynamic study of nab-Paclitaxel and solvent-based Paclitaxel in patients with metastatic or recurrent gastric cancer
Date of disclosure of the study information 2017/12/05
Last modified on 2021/12/08 11:54:37

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Basic information

Public title

Pharmacokinetic and Pharmacodynamic study of nab-Paclitaxel and solvent-based Paclitaxel in patients with metastatic or recurrent gastric cancer

Acronym

PK/PD study of nab-PTX and solvent-based PTX in metastatic GC

Scientific Title

Pharmacokinetic and Pharmacodynamic study of nab-Paclitaxel and solvent-based Paclitaxel in patients with metastatic or recurrent gastric cancer

Scientific Title:Acronym

PK/PD study of nab-PTX and solvent-based PTX in metastatic GC

Region

Japan


Condition

Condition

Metastatic or recurrent gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore the relationship between unbound paclitaxel concentration and neutropenia in nab-paclitaxel or solvent-based paclitaxel treatment

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Concentration of unbound paclitaxel and neutrophil count during 28 days from the commencement of nab-paclitaxel or solvent-based paclitaxel administration

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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) Gastric or esophagogastric cancer
2) Histologically proven adenocarcinoma or special type (carcinoid tumor and endocrine carcinoma are excluded)
3) Metastatic or recurrent disease
4) ECOG PS 0-2
5) Refractory or intolerant to fluoropyrimidine

Key exclusion criteria

1) Active infection
2) Women who is pregnant, suspected of being pregnant, within 28 days of postparturition, or lactating
3) Coexisting psychiatric disease
4) Continuous use of immune-suppressive agent
5) Known hypersensitivity to paclitaxel or albumin compound

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hirofumi
Middle name
Last name Yasui

Organization

Shizuoka Cancer Center

Division name

Division of Gastrointestinal Oncology

Zip code

411-8777

Address

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Email

h.yasui@scchr.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Tsushima

Organization

Shizuoka Cancer Center

Division name

Division of Gastrointestinal Oncology

Zip code

411-8777

Address

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Homepage URL


Email

t.tsushima@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Pharmaceutics, School of Medicine, Keio University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka Cancer Center

Address

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

Tel

055-989-5222

Email

m.takahashi@scchr.jp


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

静岡県立静岡がんセンター(静岡県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 05 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

24

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Unexpected delay

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

No longer recruiting

Date of protocol fixation

2017 Year 09 Month 14 Day

Date of IRB

2017 Year 12 Month 11 Day

Anticipated trial start date

2017 Year 12 Month 12 Day

Last follow-up date

2019 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 02 Month 28 Day

Date analysis concluded

2022 Year 08 Month 31 Day


Other

Other related information

Blood sampling 6 times on days 1 through 2, then once a week for 28 days from the commencement of nab-paclitaxel or solvent-based paclitaxel administration


Management information

Registered date

2017 Year 12 Month 05 Day

Last modified on

2021 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034583


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name