UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021849
Receipt number 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 10:32:33

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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 or person

Institute

Fudan University Shanghai Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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