UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013758 |
|---|---|
| Receipt number | R000016059 |
| Scientific Title | Single-arm, open label, clinical trial of cabazitaxel to assess safety and efficacy in Japanese patients with castration resistant prostate cancer (CRPC) previously treated with a docetaxel-containing regimen |
| Date of disclosure of the study information | 2014/04/20 |
| Last modified on | 2015/04/20 08:35:33 |
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Basic information
Public title
Single-arm, open label, clinical trial of cabazitaxel to assess safety and efficacy in Japanese patients with castration resistant prostate cancer (CRPC) previously treated with a docetaxel-containing regimen
Acronym
CABAZITAXEL
Scientific Title
Single-arm, open label, clinical trial of cabazitaxel to assess safety and efficacy in Japanese patients with castration resistant prostate cancer (CRPC) previously treated with a docetaxel-containing regimen
Scientific Title:Acronym
CABAZITAXEL
Region
| Japan |
Condition
Condition
castration resistant prostate cancer(CRPC)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate safety and efficacy of cabazitaxel in patients with CRPC previously treated with a docetaxel-containing regimen.
Efficacy will be evaluated as an exploratory objective.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data collected for the assessment of safety:
- Number of cycles, cumulative dose received, and reason for End of Treatment (EOT)
- Adverse Events (AEs), Serious Adverse Events (SAEs)
Data collected for the assessment of efficacy
- Prostate specific antigen (PSA), Tumor response according to RECIST, TTF, OS
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
Patients will receive cabazitaxel at a dose of 25 mg/m2 intravenously every 3 weeks in 1 hour. In addition, patients will receive oral prednisolone 10 mg daily throughout the cycle.
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
Key inclusion criteria
1) Age 20 or over
2)Castration resistant prostate cancer (CRPC) previously treated with a docetaxel-containing regimen
3) Surgical or medical castration
4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
5) Life-expectancy >= 3 months
6) Adequate bone marrow, liver, and renal function: Neutrophils > 1500 /mm3; Hemoglobin > 9.0 g /dL; Platelets > 100 x10^9/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5XULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min should be excluded.
7) Signed written informed consent obtained prior to enrollment
Key exclusion criteria
1)Prior radiotherapy to >= 40% of bone marrow
2)Prior surgery, radiation or chemotherapy within 4 weeks prior to enrolment (this 4-week wash-out period is aimed to allow the patient to recover from any side effects of previous therapy)
3)Active grade >=2 peripheral neuropathy
4)Active grade >=2 stomatitis
5)Active infection requiring systemic antibiotic or anti-fungal medication
6)Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for within 5 years (except superficial non-melanoma skin cancer)
7)Known brain or leptomeningeal involvement
8)History of severe hypersensitivity reaction (>=grade 3) to docetaxel
9)History of severe hypersensitivity reaction (>=grade 3) to cabazitaxel
10)History of severe hypersensitivity reaction (>=grade 3) to polysorbate 80 containing drugs
11)History of severe hypersensitivity reaction (>=grade 3) or intolerance to prednisolone
12)Uncontrolled severe illness or medical condition (including uncontrolled cardiac arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of congestive heart failure or myocardial infarction within last 6 months is also not allowed.
13)Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
14)Treatment with any investigational drug within 4 weeks prior to enrolment
15)Patient with reproductive potential not implementing accepted and effective method of contraception
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuaki Matsubara |
Organization
National Cancer Center Hospital East
Division name
Department of Breast and Medical Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
cbz_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Matsubara |
Organization
National Cancer Center Hospital Eas
Division name
Department of Breast and Medical Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
cbz_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital Exploratory Oncology Research &Clinical Trial Center
Institute
Department
Personal name
Funding Source
Organization
Cabazitaxel are founded by Sanofi .This trial are conducted as a pilot project of expand access program in japan sponsored by Ministry of Health Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 04 | Month | 20 | 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
| 2014 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 18 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2015 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016059
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| Registered date | File name |
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