Evaluating the Safety and Efficacy of SB Injection in Pat... | NCT01308645

Studies
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)

NCT01308645

Sponsor

SBPharmaceutical IND, Co., LTD

Status

Unknown status

Last Update Posted

Jun 10, 2011Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

SB injection

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Mar 2, 2011

First Submission Date that Met QC Criteria

Mar 3, 2011

First Posted Date

Mar 4, 2011Estimated

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

Jun 8, 2011

Last Update Posted Date

Jun 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).

Detailed Description

All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy wll be evaluated every 3 cycles.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SB injection	Drug	Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluating Tumor Response Rate		4 Months

Secondary Outcomes

Measure	Description	Time Frame
Pain Scores on the Visual Analog Scale		4 Months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale		4 Months
Determine duration of response rate by measuring time to progression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18 years or over
Patients with Hepatocellular carcinoma progression (HCC) and primary liver cancer as a diagnostic imaging test (eg, X-ray, CT, scan, ultrasound) can be measured in patients with a lesion
Directly to standard therapy (surgery, RF ablation, TACE) is not possible, patients with advanced liver cancer. However, the standard treatment of the subject or subjects entirely voluntary participation of subjects participating at the discretion of the doctor or researcher can be deemed included in the selected target.
Life expectancy ≥ 5 months
ECOG status 0, 1, 2 patients
Child-Pugh classification A, B patients
PLT 70,000, ANC 1,000 or more patients (OT / PT \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lee Jin woo, Prof.	Contact	82-32-3598		jin@inha.ac.kr
Lee Ji yeon, RN/BSc	Contact	82-32-890-1133		twindleclara@inha.com

Overall Officials

Name	Affiliation	Role
Lee Jin woo, Prof.	Inha University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inha University Hospital	Recruiting	Incheon	Jung-gu		South Korea

Label	URL
Link Text : SBP	View source

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided