Continuous Endostar Infusion Combined With Radiotherapy i... | NCT01410370

Studies
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

NCT01410370

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Apr 24, 2013Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Brain Metastases

Interventions

6MV-X ray
Endostar

Countries

China

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

Apr 2013

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

Jun 2011

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jul 20, 2011

First Submission Date that Met QC Criteria

Aug 4, 2011

First Posted Date

Aug 5, 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

Apr 22, 2013

Last Update Posted Date

Apr 24, 2013Estimated

Name	Class
The First People's Hospital of Lianyungang	OTHER

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 aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Experimental	Radiotherapy plus Endostar	Radiation: 6MV-X ray Drug: Endostar
control	Active Comparator	Radiotherapy	Radiation: 6MV-X ray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
6MV-X ray	Radiation	3Gy/time, 5 times/week, a total of 10 times	control treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)		1 month after initial treatment

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival		2 year
Serum VEGF Levels		at baseline and 1 month after initial treatment
VEGF levels in tumor tissue

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed malignancy with presence of intraparenchymal brain metastases
Karnofsky performance status ≥ 40
Measurable disease according to RECIST criteria
Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
Renal function: Cr ≤ 2.0×ULN
Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN
Adequate cardiac function
Life expectancy ≥ 3 months

Exclusion Criteria:

Evidence of bleeding diathesis or serious infection
Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
Uncontrollable mental and nervous disorders
Pregnant or lactating women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaodong Jiang, MD	Contact	86-0518-85605120

Overall Officials

Name	Affiliation	Role
Xiaodong Jiang, MD	The First People's Hospital of Lianyungang	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First People's Hospital of Lianyungang	Recruiting	Lianyungang	Jiangsu	222002	China

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522911	endostar protein

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided