A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708006
• Other study ID #: HGS1029-C1078
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2008
• Last updated: November 5, 2013
• Start date: May 2008
• Est. completion date: January 2012

Study information

• Verified date: November 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed advanced solid malignancy

• Life expectancy of at least 3 months

• Age 18 years or older

• Acceptable liver function

• Acceptable renal function

• Acceptable hematologic status

Exclusion Criteria:

• Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment.

• Received non-investigational agent within 3 weeks before enrollment.

• Progressive CNS involvement including the need of corticosteroids

• Pregnant or breast-feeding women

• Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1

• Known HIV infection

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• HGS1029
Escalating doses by IV (in the vein), on days 1, 8 and 15 of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	Stanford University Dept. of Medicine-Oncology	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks		throughout the study	Yes
Secondary	Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity		throughout the study	No