UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015260 |
|---|---|
| Receipt number | R000017743 |
| Scientific Title | Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy. |
| Date of disclosure of the study information | 2014/09/26 |
| Last modified on | 2019/03/31 18:33:45 |
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Basic information
Public title
Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.
Acronym
Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.
Scientific Title
Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.
Scientific Title:Acronym
Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.
Region
| Japan |
Condition
Condition
urothelial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To see the efficacy and safety of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Safety, Progression free survival, Overall survival
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
Nab-paclitaxel (260mg/m2) will be administered every 3 weeks.
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
Male and Female
Key inclusion criteria
1) ECOG performance status 0~2
2) Patients with cytologically and/or histologically confirmed urothelial carcinoma
3) Patients with metastatic or unresectable urothelial cancer previously treated cisplatin-based chemotherapy
4) At least one or more measurable lesion by RECIST ver1.1
5) Laboratory requirements
a) WBC >=3000/mm3
b) neutrophil >=1500/mm3
c) Hemoglobin >=9.0g
d) Platelet >=100000/mm3
e) Total bilirubin <=1.5 times of upper limit of normal
f) AST and ALT <=2.5 times of upper limit of normal
g) serum Creatinine <=1.5mg/dL
h) Normal ECG
6) Life expectancy more than three months
7) Signed informed consent is obtained prior to the entry to this clinical study.
Key exclusion criteria
Patients
1) have a treatment history of paclitaxel treatment
2) have an allergy to albumin
3) have a heavy infection
4) have severe complications: interstitial pulmonary fibrosis, gastrointestinal hemorrhage, ileus, uncontrollable diabetes mellitus, cardiovascular disease, etc.
5) have an uncontrollable pleural, ascites or pericardial effusion.
6) have an active cancer except urothelial cancer: cancer free duration < 5 years.
7) have a brain metastasis with symptoms requiring steroids or anti-seisure medications
8) have a history of salvage radiation to primary organ or lymph node metastasis within two weeks.
9) do not meet the inclusion criteria due to mental disorders or neurological symptoms
10) have no intention to birth control
11) disqualified by a doctor in charge
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Yano |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Urology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3673
yanoaki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Yano |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Urology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3673
Homepage URL
yanoaki@saitama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Saitama Medical Center, Saitama Medical University
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
| 2014 | Year | 09 | Month | 26 | 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
| 2013 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017743
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