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

NCT ID: NCT01013818

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.

Detailed Description

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Conditions

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Lymphoid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HGS1029

Group Type EXPERIMENTAL

HGS1029

Intervention Type 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.

Interventions

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HGS1029

HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Genome Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Oxford Cancer and Haematology Centre

Headington, Oxford, United Kingdom

Site Status

The Institute of Cancer Research

Belmont, Sutton, Surrey, , United Kingdom

Site Status

Cancer Research UK Centre

Southampton, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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HGS1029-C1080

Identifier Type: -

Identifier Source: org_study_id