UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of apatinib in the treatment of metastatic penile cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Sheng Zhang
Organization	Fudan University Shanghai Cancer Center
Division name	medical oncology
Address	270 Dongan road, shanghai
TEL	21-64175590
Email	wozhangsheng@hotmail.com

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

Sponsor
Institute	Fudan University Shanghai Cancer Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025196