Efficacy and Safety Study of ELIGARD 22.5mg With Prostate... | NCT01511874

Studies
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

NCT01511874

Sponsor

HanAll BioPharma Co., Ltd.

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Prostate Cancer

Interventions

ELIGARD 22.5mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

May 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 13, 2012

First Submission Date that Met QC Criteria

Jan 18, 2012

First Posted Date

Jan 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ELIGRAD 22.5mg	Experimental	a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks	Drug: ELIGARD 22.5mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ELIGARD 22.5mg	Drug	a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks	ELIGRAD 22.5mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg		4weeks

Secondary Outcomes

Measure	Description	Time Frame
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks		24weeks
Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks		24weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male of 20 years or above
Subject with prostate cancer with TNM stage T2~4NxMx
Blood testosterone concentration ≥ 100ng/dl
Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
WHO ECOG performance status ≤ 2
Signed written informed consent

Exclusion Criteria:

Hormone-Refractory Prostate cancer
Brain metastasis
Another primary malignant tumor except for prostate cancer
Other conditions which in the opinion of the investigator preclude enrollment into the study

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Byung Ha Chung, Medicine	Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C493311	luprolide acetate gel depot

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided