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Completed

NCT Number: NCT00708006

A Study of HGS1029 (AEG40826-2HCl) in Subjects 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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University Dept. of Medicine-Oncology, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGS1029

Drug

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

Primary outcomes

  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 outcomes

  1. Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity

    Time frame: throughout the study

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Human Genome Sciences Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jul 2, 2008
Registry last updated
Nov 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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