UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011693 |
|---|---|
| Receipt number | R000013672 |
| Scientific Title | Pharmacokinetics, pharmacodynamics and pharmacogenetics study of eribulin mesylate in patients with unresectable advanced or recurrent breast cancer |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2013/09/09 23:49:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pharmacokinetics, pharmacodynamics and pharmacogenetics study of eribulin mesylate in patients with unresectable advanced or recurrent breast cancer
Acronym
Pharmacokinetics, pharmacodynamics and pharmacogenetics study of eribulin mesylate
Scientific Title
Pharmacokinetics, pharmacodynamics and pharmacogenetics study of eribulin mesylate in patients with unresectable advanced or recurrent breast cancer
Scientific Title:Acronym
Pharmacokinetics, pharmacodynamics and pharmacogenetics study of eribulin mesylate
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
By the blood drug concentration measurement, we will reveal the characteristics of the pharmacokinetics / pharmacodynamics of plasma eribulin in patients with elderly, ECOG performance status failure, or organ dysfunction patients, especially.
Furthermore, we will perform a correlated analysis of eribulin toxicity and pharmacokinetic / pharmacodynamic.
In addition, we consider the predictive factors of high-risk patients who require postponement of eribulin administration, discontinuation, or dose reduction. As one of the predictive factor, we consider the pharmacokinetics control factors such as eribulin transporter. We will analyze the gene polymorphism of transporters, and carry out correlation analysis of adverse events and pharmacogenetic features.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-Pharmacokinetic analysis of eribulin
-Correlation between effectiveness/toxicity and pharmacokinetics of eribulin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eribulin mesylate administer day 1, day 8, tri-weekly interval. The trial treatment will be continued until there is progressive disease. we will evaluate the variation of eribulin pharmacokinetics at cycle1 day1.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
a)Histological confirmation of invasive breast cancer
b)Unresectable locally advanced cases (T4 case) or recurrent breast cancer
c)It does not matter dosing history of anthracycline, taxane, vinca alkaloid agents, 5-FU-based anti-cancer agent (UFT, capecitabine, S-1).
d)Patients with no treated with eribulin.
e)Patients wit 75 years of age 20 years of age or older obtaining informed consent
f)PS (ECOG) 0 to 2
g)Patients with passed for more than 2 weeks from prior treatment (chemotherapy, radiation therapy, hormon therapy).
h)Patients with the following values in their latest laboratory tests
-Neutrophil count > 1,000/mm3
-Platelet count > 75,000/mm3
-Hemoglobin > 9.0/dL
-Serum AST/ALT < 5 x Upper Normal Limits
-Serum creatinine < 1.5 mg/dL
Key exclusion criteria
a)Patients with brain metastases with symptoms
b)Patients with the body cavity fluid marked (pleural effusion, ascites, pericardial effusion). However, it can be registered if good control due to the administration of adhesion agent.
c)Patients with synchronous double cancer, not including lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy
d)Patients with complications is determined causing serious problems in the implementation of treatment
- Patients with poor control diabetes
- Patients with activity infection
- Patients with pulmonary fibrosis or interstitial pneumonia on chest X-ray
- Patient with protocol difficult-to-treat caused by the mental state or neuropsychiatric disorders
- Patients with watery diarrhea chronic
- Patients with ileus, significant bleeding tendency, and gastrointestinal bleeding
- Patients with uncontrolled angina and myocardial infarction and heart disease merger severe cases with heart failure that developed within three months
e)Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Tamura |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo104-0045, Japan
TEL
03-3542-2511
ketamura@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tamura |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo104-0045, Japan
TEL
03-3542-2511
Homepage URL
ketamura@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2013 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
