Solid Tumor CancerPhase 1NCT00085904
Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas
A Phase 1 study testing SB-485232 in people with Solid Tumor Cancer and Lymphoma, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Lymphoma
- What is being tested?
- SB-485232
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to not given
- 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
- Histopathological confirmation of cancer limited to a solid tumor malignancy or follicular lymphoma.
- Advanced or metastatic disease.
- Measurable disease.
- Females of child-bearing potential must use adequate birth control.
- Karnofsky Performance Status of 70% or greater.
- Predicted life expectancy of at least 12 weeks in the estimation of the physician conducting the study (Principal Investigator).
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- Adequate laboratory results.
- Subjects with history of coronary artery disease must have a stress test without clinically significant abnormalities.
- Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy, must have a MUGA (Multiple Gated Acquisition) scan which demonstrates a left ventricular ejection fraction equal to or greater than 40%.
- Signed informed consent form
Who cannot join
- Female subject is pregnant or nursing (lactating).
- Active, chronic or uncontrolled infections requiring systemic antibiotic therapy.
- Serious medical or psychiatric disorder that would interfere with the subject''s safety or ability to sign the informed consent.
- Leptomeningeal disease or evidence of prior or current metastatic brain disease.
- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, corticosteroid therapy, or investigational therapy.
- Received chemotherapy, radiotherapy, immunotherapy, hormonal therapy or biological therapy for cancer or underwent a surgical procedure (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks in case of nitrosureas or mitomycin C).
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- Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232.
- Severe concurrent disease or condition, including clinically significant autoimmune disease, which in the judgement of the physician conducting the study (the principal investigator) would render the patient inappropriate for study participation.
- History of ventricular arrhythmias requiring drug or device therapy.
- An unresolved or unstable, serious toxicity from prior administration of another investigational product.
- Psychological, familial, sociological, or geographical limitations that do not permit compliance with this protocol.
- Received prior SB-485232 therapy.
- Poor venous access.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213-2584
About this study
Official title: A Phase I, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Five Daily Intravenous Infusions Repeated Every 28 Days in Adult Patients With Solid Tumors and Lymphomas
SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.
- Conditions
- Solid Tumor Cancer, Lymphoma
- Being tested
- SB-485232
- Keywords
- Advanced cancer, IL-18, repeat dosing, Phase 1, pharmacokinetics, oncology
- Medical subject headings
- Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-485232Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adverse events and changes in laboratory values. The potential dose is a dose regimen with no more than 2 out of 6 patients experiencing a dose-limiting toxicity.
Measured: 6 Months
Secondary outcomes (1)
Evaluation for the presence of anti-SB-485232 antibodies, IL-18 neutralizing activity, and clinical sequelae. Pharmacokinetic endpoints are AUC, Cmax, Cmin, CL,Vss, and t1/2. Flow cytometry data. Assessments of disease.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2004 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085904
- Sponsor's protocol ID
- 485232/003
- Other IDs
- 003
- Status last verified
- Oct 2008
- First submitted
- 16 Jun 2004
- Last updated
- 13 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Five Daily Intravenous Infusions Repeated Every 28 Days in Adult Patients With Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT00085904
- Acronym / sponsor ID
- 485232/003
- Conditions
- Solid Tumor Cancer, Lymphoma
- Keywords
- Advanced cancer, IL-18, repeat dosing, Phase 1, pharmacokinetics, oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 18 Jun 2004 (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.
SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathological confirmation of cancer limited to a solid tumor malignancy or follicular lymphoma.
- Advanced or metastatic disease.
- Measurable disease.
- Females of child-bearing potential must use adequate birth control.
- Karnofsky Performance Status of 70% or greater.
Key exclusion criteria (13 listed)
- Female subject is pregnant or nursing (lactating).
- Active, chronic or uncontrolled infections requiring systemic antibiotic therapy.
- Serious medical or psychiatric disorder that would interfere with the subject''s safety or ability to sign the informed consent.
- Leptomeningeal disease or evidence of prior or current metastatic brain disease.
- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, corticosteroid therapy, or investigational therapy.
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 |
|---|---|---|
| SB-485232 | Drug | – |
Primary outcome
Evaluation of adverse events and changes in laboratory values. The potential dose is a dose regimen with no more than 2 out of 6 patients experiencing a dose-limiting toxicity.
Time frame: 6 Months
1 secondary outcome
Evaluation for the presence of anti-SB-485232 antibodies, IL-18 neutralizing activity, and clinical sequelae. Pharmacokinetic endpoints are AUC, Cmax, Cmin, CL,Vss, and t1/2. Flow cytometry data. Assessments of disease.
Time frame: 6 Months
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 13 Oct 2008.
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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, MD study director
GlaxoSmithKline
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 SB-485232 in people with Solid Tumor Cancer and Lymphoma, run by GlaxoSmithKline 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 10 inclusion and 13 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 13 Oct 2008. 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?
Evaluation of adverse events and changes in laboratory values. The potential dose is a dose regimen with no more than 2 out of 6 patients experiencing a dose-limiting toxicity. (time frame: 6 Months). 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 13 Oct 2008.