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

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

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

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

Time frame: throughout the study

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.

Published trials that share one or more normalized conditions with this study.

Completed