UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018721
Receipt No. 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 2017/03/25

* 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 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
Email 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
Email ashimomu@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2013 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 19 Day
Last follow-up date
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
2017 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.