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TerminatedNCT01013818Updated Aug 2, 2013

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

A Phase 1 interventional study of HGS1029 in Lymphoid Malignancies, sponsored by Human Genome Sciences Inc.. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by Human Genome Sciences Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Terminated due to slow accrual
Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Lymphoid Malignancies

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 11 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Human Genome Sciences Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    HGS1029

    Drug: HGS1029

Interventions

  • DrugHGS1029

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

06

What researchers measure

Primary outcomes

  1. Type, frequency and severity of adverse events

    Time frame: 1 year

Secondary outcomes

  1. Measure pharmacokinetic profile

    Time frame: 1st two months of the study

  2. Evaluation of pharmacodynamics

    Time frame: 1st two months of the study

  3. Evaluation of possible anti-tumor activity

    Time frame: Every 2 months while on study

07

Study locations

5 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Oxford Cancer and Haematology Centre
    Headington, Oxford OX3 7LJ, United Kingdom
  • The Institute of Cancer Research
    Belmont, Sutton, Surrey, SM2 5NG, United Kingdom
  • Cancer Research UK Centre
    Southampton, SO16 6YD, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01013818
Lead sponsor
Human Genome Sciences Inc.
Responsible party
Sponsor
First posted
Nov 16, 2009
Start date
Oct 2009
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Aug 2, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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