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

Human Genome Sciences

Status and phase: Terminated; Phase 1

Conditions: Lymphoid Malignancies

Treatments: Drug: HGS1029

Study type: Interventional

Funder types: Industry

Identifiers

NCT01013818

HGS1029-C1080

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

HGS1029

Experimental group

Treatment:

Drug: HGS1029