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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
Not Enrolling
Both
Advanced Solid Tumors

Thank you

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 CenterDenver, Colorado  80262
The Sarah Cannon Research InstituteNashville, Tennessee  37203
Stanford University Dept. of Medicine-OncologyStanford, California  94305