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.

Study Overview

• Status: Terminated
• Conditions: Lymphoid Malignancies
• Intervention / Treatment: Drug: HGS1029

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Type, frequency and severity of adverse events	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure pharmacokinetic profile	1st two months of the study
Evaluation of pharmacodynamics	1st two months of the study
Evaluation of possible anti-tumor activity	Every 2 months while on study

Collaborators and Investigators

• Sponsor: Human Genome Sciences Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HGS1029-C1080