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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708006
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: HGS1029 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors
Study Start Date : May 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

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 Name: AEG40826•2HCl




Primary Outcome Measures :
  1. To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity [ Time Frame: throughout the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708006


Locations
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United States, California
Stanford University Dept. of Medicine-Oncology
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Tennessee
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
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Study Director: Gilles Gallant, B. Pharm.,Ph.D. Human Genome Sciences Inc.
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Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00708006    
Other Study ID Numbers: HGS1029-C1078
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Neoplasms