NCT00708006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2008

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

3.6 years

First QC Date

June 30, 2008

Last Update Submit

November 5, 2013

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks

    throughout the study

Secondary Outcomes (1)

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

    throughout the study

Study Arms (1)

1

EXPERIMENTAL

HGS1029

Drug: HGS1029

Interventions

HGS1029DRUG

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

Also known as: AEG40826•2HCl
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford University Dept. of Medicine-Oncology

Stanford, California, 94305, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Study Officials

  • Gilles Gallant, B. Pharm.,Ph.D.

    Human Genome Sciences Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 2, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

US(3)