A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advan... | NCT00708006

Studies
A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors

NCT00708006

Sponsor

Human Genome Sciences Inc.

Status

Completed

Last Update Posted

Nov 7, 2013Estimated

Enrollment

66Actual

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

HGS1029

Countries

United States

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

Nov 2013

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

May 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 30, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 2, 2008Estimated

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

Nov 5, 2013

Last Update Posted Date

Nov 7, 2013Estimated

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 the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	HGS1029	Drug: HGS1029

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HGS1029	Drug	Escalating doses by IV (in the vein), on days 1, 8 and 15 of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks		throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed advanced solid malignancy
Life expectancy of at least 3 months
Age 18 years or older
Acceptable liver function
Acceptable renal function
Acceptable hematologic status

Exclusion Criteria:

Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment.
Received non-investigational agent within 3 weeks before enrollment.
Progressive CNS involvement including the need of corticosteroids
Pregnant or breast-feeding women
Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1
Known HIV infection

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

Not provided

Overall Officials

Name	Affiliation	Role
Gilles Gallant, B. Pharm.,Ph.D.	Human Genome Sciences Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Dept. of Medicine-Oncology		Stanford	California	94305	United States
University of Colorado Health Sciences Center