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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013818
Recruitment Status : Terminated (Terminated due to slow accrual)
First Posted : November 16, 2009
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Human Genome Sciences Inc.

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

Condition or disease Intervention/treatment Phase
Lymphoid Malignancies Drug: HGS1029 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Study Start Date : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: HGS1029 Drug: 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.

Primary Outcome Measures :
  1. Type, frequency and severity of adverse events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013818

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United Kingdom
Oxford Cancer and Haematology Centre
Headington, Oxford, United Kingdom, OX3 7LJ
The Institute of Cancer Research
Belmont, Sutton, Surrey, United Kingdom, SM2 5NG
Cancer Research UK Centre
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Human Genome Sciences Inc.
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Human Genome Sciences Inc. Identifier: NCT01013818     History of Changes
Other Study ID Numbers: HGS1029-C1080
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Additional relevant MeSH terms: