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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HGS1029

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Dept. of Medicine-Oncology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • The Sarah Cannon Research Institute

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; HGS1029	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; Other Names: AEG40826•2HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks	throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity	throughout the study

Collaborators and Investigators

• Sponsor: Human Genome Sciences Inc.
• Investigators: Study Director: Gilles Gallant, B. Pharm.,Ph.D., Human Genome Sciences Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: June 30, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HGS1029-C1078