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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021849
Receipt No. R000025196
Scientific Title Phase II trial of apatinib in the treatment of metastatic penile cancer
Date of disclosure of the study information 2016/04/10
Last modified on 2016/04/10

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Basic information
Public title Phase II trial of apatinib in the treatment of metastatic penile cancer
Acronym Phase II trial of apatinib in the treatment of metastatic penile cancer
Scientific Title Phase II trial of apatinib in the treatment of metastatic penile cancer
Scientific Title:Acronym Phase II trial of apatinib in the treatment of metastatic penile cancer
Region
Asia(except Japan)

Condition
Condition phase II ,single arm
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of targetted therapy with apatinib in penile cancer in a phase II trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival,
Key secondary outcomes objective response rate;

overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 apatinib 500mg qd
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
18 years-old <=
Age-upper limit
75 years-old >
Gender Male
Key inclusion criteria 1) Pathologically confirmed penile squamous cell carcinoma
2) M1 disease
3) At least one measurable tumor lesion
4) ECOG PS 0-1
5) Age 18-75
6) Normal organ function
7) Written informed consent
Key exclusion criteria 1) Usage of experimental drugs
2) History of serious drug allergy
3) uncontrolled hemorrhage
4) PS>1
5) heart failure
6) Double cancer
7) Coexisting severe medical conditions
8) Mental disease
9) Judged as inappropriate to participate this trial by investigators
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sheng Zhang
Organization Fudan University Shanghai Cancer Center
Division name medical oncology
Zip code
Address 270 Dongan road, shanghai
TEL 21-64175590
Email wozhangsheng@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Sheng Zhang
Organization Fudan University Shanghai Cancer Center
Division name medical oncology
Zip code
Address 270 Dongan Road
TEL 21-64175590
Homepage URL
Email wozhangsheng@hotmail.com

Sponsor
Institute Fudan University Shanghai Cancer Center
Institute
Department

Funding Source
Organization Fudan University Shanghai Cancer Center
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 Fudan University Shanghai Cancer Center

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 10 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
Date of protocol fixation
2016 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 11 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
2016 Year 04 Month 10 Day
Last modified on
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025196

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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