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

Phase 1

Terminated

• Conditions: Lymphoid Malignancies
• Interventions: Drug: HGS1029

• Registration Number: NCT01013818
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HGS1029	HGS1029	-

Primary Outcome Measures

Name	Time	Method
Type, frequency and severity of adverse events	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

The Institute of Cancer Research; 🇬🇧 Belmont, Sutton, Surrey, United Kingdom

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Oxford Cancer and Haematology Centre; 🇬🇧 Headington, Oxford, United Kingdom

Cancer Research UK Centre; 🇬🇧 Southampton, United Kingdom