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

This study has been terminated.
(Terminated due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01013818
First received: November 3, 2009
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Lymphoid Malignancies
 Drug: HGS1029
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Type, frequency and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure pharmacokinetic profile [ Time Frame: 1st two months of the study ] [ Designated as safety issue: No ]
  • Evaluation of pharmacodynamics [ Time Frame: 1st two months of the study ] [ Designated as safety issue: No ]
  • Evaluation of possible anti-tumor activity [ Time Frame: Every 2 months while on study ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013818

Locations
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., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01013818     History of Changes
Other Study ID Numbers: HGS1029-C1080
Study First Received: November 3, 2009
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013