Solid Tumor CancerPhase 1NCT00136513
SB-743921 In Patients With Solid Tumors
A Phase 1 study testing SB-743921 in people with Solid Tumor Cancer, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed by 1-hour intravenous infusion every 3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer
- What is being tested?
- SB-743921
- How many people
- 30 participants
- Where
- 2 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
- Histologically or cytologically confirmed diagnosis of: a) Advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy; OR b) B-cell or T-cell lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) AND/OR for which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not indicated or has been refused by the patient.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
Who cannot join
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- Absolute neutrophil count less than 1,500/mm3.
- Platelets less than 100,000/mm3.
- Hemoglobin less than 9 g/dL.
- Total bilirubin greater than1.5 mg/dL.
- AST/ALT greater than 2.5 X upper limit of normal.
- Creatinine clearance less than or equal to 60 mL/min.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With Solid Tumors
The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of the drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-743921. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
- Conditions
- Solid Tumor Cancer
- Being tested
- SB-743921
- Keywords
- Safety, tolerability, dose limiting toxicity, solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-743921Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will include evaluation of adverse events (AE) and changes from baseline in vital signs and clinical laboratory parameters. PK endpoints will include Cl, Vd, AUC, Cmax, and t½.
Secondary outcomes (1)
Tumor response Comparison of pre and post-dose biomarker levels and/or correlation of pre-dose biomarker levels to any subsequent tumor response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (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
- 30 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
- NCT00136513
- Sponsor's protocol ID
- 743921/001
- Status last verified
- Oct 2008
- First submitted
- 25 Aug 2005
- Last updated
- 16 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00136513
- Acronym / sponsor ID
- 743921/001
- Conditions
- Solid Tumor Cancer
- Keywords
- Safety, tolerability, dose limiting toxicity, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 29 Aug 2005 (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 find a dose of SB-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of the drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-743921. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
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 (2 listed)
- Histologically or cytologically confirmed diagnosis of: a) Advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy; OR b) B-cell or T-cell lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) AND/OR for which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not indicated or has been refused by the patient.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
Key exclusion criteria (8 listed)
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- Absolute neutrophil count less than 1,500/mm3.
- Platelets less than 100,000/mm3.
- Hemoglobin less than 9 g/dL.
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-743921 | Drug | – |
Primary outcome
Safety and tolerability will include evaluation of adverse events (AE) and changes from baseline in vital signs and clinical laboratory parameters. PK endpoints will include Cl, Vd, AUC, Cmax, and t½.
1 secondary outcome
Tumor response Comparison of pre and post-dose biomarker levels and/or correlation of pre-dose biomarker levels to any subsequent tumor response.
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 16 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
2 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-743921 in people with Solid Tumor Cancer, run by GlaxoSmithKline at 2 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 2 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: finished, as of the sponsor's last update on 16 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 2 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?
Safety and tolerability will include evaluation of adverse events (AE) and changes from baseline in vital signs and clinical laboratory parameters. PK endpoints will include Cl, Vd, AUC, Cmax, and t½.. 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 16 Oct 2008.