UMIN-CTR Clinical Trial

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
Institute	Shizuoka Cancer Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034583