A Study of HGS1029 in Subjects With Relapsed or Refractor... | NCT01013818

Studies
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies

NCT01013818

Sponsor

Human Genome Sciences Inc.

Status

Terminated

Last Update Posted

Aug 2, 2013Estimated

Enrollment

11Actual

Phase

Phase 1

Conditions

Lymphoid Malignancies

Interventions

HGS1029

Countries

United States
United Kingdom

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to slow accrual

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Nov 3, 2009

First Submission Date that Met QC Criteria

Nov 13, 2009

First Posted Date

Nov 16, 2009Estimated

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

Aug 1, 2013

Last Update Posted Date

Aug 2, 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

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HGS1029	Experimental		Drug: HGS1029

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HGS1029	Drug	HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.	HGS1029

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type, frequency and severity of adverse events		1 year

Secondary Outcomes

Measure	Description	Time Frame
Measure pharmacokinetic profile		1st two months of the study
Evaluation of pharmacodynamics		1st two months of the study
Evaluation of possible anti-tumor activity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed relapsed/refractory lymphoid malignancies
Previously treated with at least 2 therapeutic regimens
ECOG performance < 2.
Life expectancy of at least 3 months
Adequate renal function
Adequate hematologic status
Adequate liver function
Transfusion independent

Exclusion Criteria:

Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
Known HIV infection
Positive for hepatitis B surface antigen or positive hepatitis C antibody
Grade 2 or greater neuropathy
Pregnant female or nursing mother
Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029

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
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States
Hackensack University Medical Center