UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018721 |
|---|---|
| Receipt number | R000021660 |
| Scientific Title | Pharmacokinetic, pharmacodynamic and biomarker study of phase I/II study of olaparib in combination with eribulin mesylate for patients with recurrent or metastatic triple-negative-type breast cancer |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2021/08/23 10:27:08 |
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Basic information
Public title
Pharmacokinetic, pharmacodynamic and biomarker study of phase I/II study of olaparib in combination with eribulin mesylate for patients with recurrent or metastatic triple-negative-type breast cancer
Acronym
Pharmacokinetic, pharmacodynamic and biomarker study of Eribulin and Olaparib study
Scientific Title
Pharmacokinetic, pharmacodynamic and biomarker study of phase I/II study of olaparib in combination with eribulin mesylate for patients with recurrent or metastatic triple-negative-type breast cancer
Scientific Title:Acronym
Pharmacokinetic, pharmacodynamic and biomarker study of Eribulin and Olaparib study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1. Analyze the pharmacokinetics of Olaparib and Eribulin in a patient with breast cancer and investigate its interaction as well as analyzing the relationship between pharmacokinetics and efficacy or adverse events.
2. Determine the inhibitory activity of the poly(ADP-ribose) polymerase (PARP) in the peripheral blood mononuclear cell (PBMC) and analyze the relationship with the dose and the plasma exposure. In addition, determine the poly(ADP-ribose) metabolites in plasma and urine samples and analyze the relationship to the PARP inhibitory activity. Furthermore, analyze the relationship between the PARP inhibitory activity and the efficacy.
3. Explore a biomarker to identify a population that has benefit from Olaparib and Eribulin.
4. Analyze the relationship between the extent of Olaparib and Eribulin accumulation in a tumor and the therapeutic effect.
5. Explore a biomarker that leads to therapeutic effect or acquisition of treatment resistance.
6. Explore BRCA 1/2 germline mutations in the blood DNA and BRCA 1/2 somatic mutations in a tumor tissue.
7. Investigate, the expression and mutations of a gene that relates to gene repairs of a tumor tissue.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical efficacy and safety
Pharmacokinetics
Pharmacodynamics
Biomarkers
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A patient who gives informed consent to "A phase I/II Study of Olaparib with Eribulin for inoperable or recurrent triple negative breast cancer with a history of anthracyclines and taxanes"
2. A patient who gives written informed consent
Key exclusion criteria
Patient considered irrelevant by attending physician for the study
Target sample size
66
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
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
ketamura@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Shimomura |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
ashimomu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One year follow up after last patient in
Biomarker study of UMIN000009498
Management information
Registered date
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021660
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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