Advanced Solid TumorsPhase 1NCT00708006
A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors
A Phase 1 study testing HGS1029 in people with Advanced Solid Tumors, run by Human Genome Sciences Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HGS1029
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Stanford University Dept. of Medicine-Oncology
Stanford, California, 94305
About this study
Official title: A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- HGS1029
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGS1029Drug
Also called AEG40826•2HCl
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HGS1029 Receives: Drug: HGS1029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks
Measured: throughout the study
Secondary outcomes (1)
Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilles Gallant, B. Pharm.,Ph.D., Study director, Human Genome Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708006
- Sponsor's protocol ID
- HGS1029-C1078
- Status last verified
- Nov 2013
- First submitted
- 30 Jun 2008
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00708006
- Acronym / sponsor ID
- HGS1029-C1078
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Human Genome Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HGS1029HGS1029 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed advanced solid malignancy
- Life expectancy of at least 3 months
- Age 18 years or older
- Acceptable liver function
- Acceptable renal function
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGS1029Also: AEG40826•2HClEscalating 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 | Drug | 1 |
Primary outcome
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks
Time frame: throughout the study
1 secondary outcome
Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Gallant, B. Pharm.,Ph.D. study director
Human Genome Sciences Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HGS1029 in people with Advanced Solid Tumors, run by Human Genome Sciences Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.