A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors
- Registration Number
- NCT00708006
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 HGS1029 HGS1029
- Primary Outcome Measures
Name Time Method To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks throughout the study
- Secondary Outcome Measures
Name Time Method Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity throughout the study
Trial Locations
- Locations (3)
The Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Stanford University Dept. of Medicine-Oncology
🇺🇸Stanford, California, United States
University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States