UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015820 |
|---|---|
| Receipt number | R000018413 |
| Scientific Title | A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients. |
| Date of disclosure of the study information | 2014/12/02 |
| Last modified on | 2017/07/12 16:12:09 |
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Basic information
Public title
A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Acronym
A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Scientific Title
A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Scientific Title:Acronym
A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Region
| Japan |
Condition
Condition
advanced or recurrent breast cancer patients.
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety of Docetaxel of 100 mg/m2 to advanced or recurrent breast cancer patients
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
pharmacokinetics
pharmacodynamics
efficacy
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
Docetaxel
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)Patients aged 20 years or older at providing informed consent
(2)Patients with histopathological diagnosis of breast cancer
(3)Patients with recurrent breast cancer that is inoperable, unsuitable for radiation therapy or with stage IV breast cancer, regardless of whether they have a measurable lesion
(4)Patients with ECOG performance status (PS) 0-1 at screening
(5)Patients with functional organs as defined by the following laboratory test values at screening
Hemoglobin: 8.0 g/dL or more
Neutrophil count: 1,500/mm3 or more
Platelet count: 100,000/mm3 or more
AST (GOT), ALT (GPT): Twice the upper limit of the sites reference range or less
Total bilirubin: 1.5 mg/dL or less
Blood alkaline phosphatase: 2.5 times the upper limit of the sites reference range or less
Serum creatinine: 1.0 mg/dL or less
(6)Patients not within 2 weeks after surgery, 4 weeks after the last dose of prior chemotherapy or hormone therapy, or 2 weeks after the last dose of prior radiation therapy
(7)Patients with a life expectancy of at least 3 months
(8)Patients without excessive expression of HER2. However, patients with excessive expression of HER2 can participate in the trial if anti-HER2 therapy is not indicated
(9)Patients in whom all clinically significant toxicity related to the prior anti-cancer therapies (surgery, radiation therapy, anticancer drug) have resolved to CTCAE (v 4.0) grade 1 or below
(10)Patients who provided written informed consent of their own to participate in this trial
Key exclusion criteria
(1)Patients with a history of hypersensitivity to Docetaxel, alcohol or any drug product containing Polysorbate 80
(2)Patients with a mental disease or patients who are incapable of participating in the trial due to psychiatric symptoms
(3)Patients with any uncontrollable infection (e.g., fungi, virus, bacteria)
(4)Patients with unstable or untreated metastasis in the central nervous system
(5)Patients with any uncontrolled heart disease including cadiomyopathy, NYHA grade III or IV heart diseases, arrhythmia, unstable angina and myocardial infarction
(6)Patients with a history of treatment with Docetaxel for advanced or recurrent breast cancer. However, patients with recurrent disease can participate if the disease recurred at least 6 months after receiving the last dose of Docetaxel in a pre- and/or post-operative adjuvant chemotherapy
(7)Patients who cannot tolerate pretreatment with Dexamethasone because steroids are clinically contraindicated
(8)Patients with a history of or concurrent malignant tumor
(9)Patients positive for anti-human immunodeficiency virus antibody, those with active chronic type B or type C hepatitis.
(10)Patients with concurrent peripheral neuropathy of CTCAE (v 4.0) grade 2 or higher
(11)Women who are pregnant, possibly pregnant or are lactating
(12)Premenopausal, possibly pregnant female patients or fertile male patients who do not agree to practice contraception using medically approved methods from 2 weeks before the start of administration of the investigational product to 120 days after the completion of administration of the investigational product
(13)Patients who cannot continue the treatment under hospitalization for at least 15 days, beginning from the start of administration of the investigational product in the first course
(14)Patients otherwise unsuitable for this clinical trial in the opinion of the investigator or subinvestigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taizo Hirata, M.D., Ph.D. |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1, Shikata, Kita-ku, Okayama, 700-8558
TEL
086-235-7227
tahirata@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taizo Hirata, M.D., Ph.D. |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1, Shikata, Kita-ku, Okayama, 700-8558
TEL
086-235-7227
Homepage URL
tahirata@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Center for Innovative Clinical Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of health, labor and welfare
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
2014年8月18日
Institutions
Institutions
岡山大学病院（岡山県岡山市）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 02 | 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
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 24 | 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
| 2014 | Year | 12 | Month | 02 | Day |
Last modified on
| 2017 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018413
