Lymphoid MalignanciesPhase 1NCT01013818
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
A Phase 1 study testing HGS1029 in people with Lymphoid Malignancies, run by Human Genome Sciences Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoid Malignancies
- 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
- 11 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2009to Oct 2011
- 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 relapsed/refractory lymphoid malignancies
- Previously treated with at least 2 therapeutic regimens
- ECOG performance < 2.
- Life expectancy of at least 3 months
- Adequate renal function
- Adequate hematologic status
- Adequate liver function
- Transfusion independent
Who cannot join
- Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
- The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
- Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
- Known HIV infection
- Positive for hepatitis B surface antigen or positive hepatitis C antibody
- Grade 2 or greater neuropathy
- Pregnant female or nursing mother
- Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom3 sites
The Institute of Cancer Research
Belmont, Sutton, Surrey, SM2 5NG
Oxford Cancer and Haematology Centre
Headington, Oxford, OX3 7LJ
Cancer Research UK Centre
Southampton, SO16 6YD
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.
- Conditions
- Lymphoid Malignancies
- Being tested
- HGS1029
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGS1029Drug
HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.
| Study group | Role | What they receive |
|---|---|---|
| HGS1029 | Experimental | Not described Receives: Drug: HGS1029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, frequency and severity of adverse events
Measured: 1 year
Secondary outcomes (3)
Measure pharmacokinetic profile
Measured: 1st two months of the study
Evaluation of pharmacodynamics
Measured: 1st two months of the study
Evaluation of possible anti-tumor activity
Measured: Every 2 months while on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid MalignanciesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013818
- Sponsor's protocol ID
- HGS1029-C1080
- Status last verified
- Aug 2013
- First submitted
- 3 Nov 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT01013818
- Acronym / sponsor ID
- HGS1029-C1080
- Conditions
- Lymphoid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Human Genome Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Nov 2009 (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 determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HGS1029 | Experimental | Drug: HGS1029 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed relapsed/refractory lymphoid malignancies
- Previously treated with at least 2 therapeutic regimens
- ECOG performance < 2.
- Life expectancy of at least 3 months
- Adequate renal function
Key exclusion criteria (8 listed)
- Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
- The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
- Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
- Known HIV infection
- Positive for hepatitis B surface antigen or positive hepatitis C antibody
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 |
|---|---|---|
| HGS1029HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off. | Drug | HGS1029 |
Primary outcome
Type, frequency and severity of adverse events
Time frame: 1 year
3 secondary outcomes
Measure pharmacokinetic profile
Time frame: 1st two months of the study
Evaluation of pharmacodynamics
Time frame: 1st two months of the study
Evaluation of possible anti-tumor activity
Time frame: Every 2 months while on study
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: 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 Lymphoid Malignancies, run by Human Genome Sciences Inc. at 5 sites in 2 countries.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, 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 was stopped early (reason given: Terminated due to slow accrual). Results are not available in the source record.
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?
Type, frequency and severity of adverse events (time frame: 1 year). 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 2 Aug 2013.