A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
Trial Information
A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks
Outcome Time Frame:
throughout the study
Safety Issue:
Yes
Principal Investigator
Gilles Gallant, B. Pharm.,Ph.D.
Investigator Role:
Study Director
Investigator Affiliation:
Human Genome Sciences Inc., a GSK Company
Authority:
United States: Food and Drug Administration
Study ID:
HGS1029-C1078
NCT ID:
NCT00708006
Start Date:
May 2008
Completion Date:
January 2012
Related Keywords:
- Advanced Solid Tumors
- Neoplasms
Name | Location |
|---|---|
| University of Colorado Health Sciences Center | Denver, Colorado 80262 |
| The Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Stanford University Dept. of Medicine-Oncology | Stanford, California 94305 |
