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
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
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
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
