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

NCT ID: NCT00708006

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

HGS1029

Group Type EXPERIMENTAL

HGS1029

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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AEG40826•2HCl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Genome Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Gallant, B. Pharm.,Ph.D.

Role: STUDY_DIRECTOR

Human Genome Sciences Inc.

Locations

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Stanford University Dept. of Medicine-Oncology

Stanford, California, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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HGS1029-C1078

Identifier Type: -

Identifier Source: org_study_id