Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT01013818
First received: November 3, 2009
Last updated: August 1, 2013
Last verified: August 2013

November 3, 2009
August 1, 2013
October 2009
October 2011   (final data collection date for primary outcome measure)
Type, frequency and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01013818 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoid Malignancies
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.
Experimental: HGS1029
Intervention: Drug: HGS1029
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01013818
HGS1029-C1080
No
Human Genome Sciences Inc.
Human Genome Sciences Inc.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
Human Genome Sciences Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP