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

Lymphoid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01013818
• Other study ID #: HGS1029-C1080
• Status: Terminated
• Phase: Phase 1
• First received: November 3, 2009
• Last updated: August 1, 2013
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoid Malignancies
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The Institute of Cancer Research	Belmont, Sutton, Surrey
United Kingdom	Oxford Cancer and Haematology Centre	Headington	Oxford
United Kingdom	Cancer Research UK Centre	Southampton
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, frequency and severity of adverse events		1 year	Yes
Secondary	Measure pharmacokinetic profile		1st two months of the study	No
Secondary	Evaluation of pharmacodynamics		1st two months of the study	No
Secondary	Evaluation of possible anti-tumor activity		Every 2 months while on study	No