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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013758
Receipt No. 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

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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
Email 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
Email cbz_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital Exploratory Oncology Research &Clinical Trial Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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