UMIN-CTR Clinical Trial

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
Last 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
Email	yanoaki@saitama-med.ac.jp

Public contact
1st 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
Email	yanoaki@saitama-med.ac.jp

Sponsor
Institute	Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017743