UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009716 |
|---|---|
| Receipt number | R000011392 |
| Scientific Title | Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2013/01/07 17:50:05 |
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Basic information
Public title
Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane
Acronym
Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane
Scientific Title
Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane
Scientific Title:Acronym
Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane
Region
| Japan |
Condition
Condition
Advanced and recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The maximum tolerated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of eribulin and S1 in patients with progressive recurring breast cancer, and the recommended dose (RD) for Phase II clinical study will be determined.
Basic objectives2
Others
Basic objectives -Others
Dosage finding
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
DLT;Dose Limiting Toxicity
MTD;Maximum Tolerated Dose
Key secondary outcomes
Overall response rate, Progression free survival, Adverse Event
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
Combination therapy of Eribulin and S1
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
(1)histlogically or cytologically confirmed breast cancer.
(2) patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence.
(3) patients without history of prior treatment with eribulin and S1.
(4) patients at least 20 years of age but not older than 75 at the time of informed.
(5) ECOG perfomance status 0-1.
(6) patients with evaluable lesion by RECIST criteria.
(7) required baseline laboratory parameters (within 2 weeks before registration)
WBC >3,000/mm3 , neutrophil >1,500/mm3
Plt >100,000/mm3
Hb >9.0g/dL
AST and ALT <=100IU/L
total bilirubin <=1.5mg/dL
creatinine clearance <=60 ml/min
(8) no carry-over effect or side effect that could affect the study outcome of prior treatment (without alopecia and neuropathy of grade 1).
(9) written informed consent was obtained
(10) with life expectancy greater than 3 months.
Key exclusion criteria
(1) with symptoms of infectious disease
(2) pleural effusion, peritoneal effusion which needs drainage
(3) brain metastasis with the necessity of treatment
(4) patients with following serious complication
1) Ischemic heart disease and arrhythmic cardiac disease with poor control.
2) ischemic heart disease within 6 months,
3) liver cirrhosis,
4) watery diarrhea
5) interstitial pneumonia or pulmonary fibrosis by chest radiograph
6) bleeding tendency
7) another serious complication
(5) patients who need to receive continuous corticosteroid administration
(6) positive for HBs antigen
(7) patients who treated by widespread radiation therapy
(8) pregnant or nursing women
(9) patients who are participating in the other clinical trial
(10) patients who judged improper to entry this trial by physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakagawa |
Organization
Kinki University Hospital, Faculty of medicine
Division name
Depertment of medical oncology
Zip code
Address
377-2 Ohnohigashi, Osakasayama City, Osaka, Japan
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Tsurutani |
Organization
Kinki University Hospital, Faculty of medicine
Division name
Depertment of medical oncology
Zip code
Address
377-2 Ohnohigashi, Osakasayama City, Osaka, Japan
TEL
072-366-0221
Homepage URL
Sponsor or person
Institute
Depertment of medical oncology, Kinki University Hospital, Faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 07 | 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
| 2012 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2013 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011392
