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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030277
Receipt No. 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 2019/06/07

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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
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
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 Open public 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
Date analysis concluded
2020 Year 04 Month 30 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
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.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


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