- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00085878
Dose-Escalation Study Of SB-485232 Administered As Daily Subcutaneous Injections In Adults With Solid Tumors
October 15, 2008 updated by: GlaxoSmithKline
A Phase I, Dose Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Daily Subcutaneous Injections in Adult Patients With Solid Tumors
This is a phase I, open-label, dose-escalation study of SB-485232.
Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days.
Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested.
An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks.
Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90404-2104
- GSK Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46202
- GSK Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27705
- GSK Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of malignancy.
- Subjects with solid tumors must have locally advanced or metastatic disease at the time of enrollment.
- Measurable or evaluable disease that is refractory or resistant to standard therapy or for which there is no effective standard therapy.
- Predicted life expectancy of at least 12 weeks.
- Kinesin spindle protein (KPS) of greater than 70%.
- No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks for nitrosoureas and mitomycin C).
- Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study.
- Provide written informed consent.
- Absence of anti-SB-485232 antibodies.
- Hemoglobin greater than or equal to 9 g/dL.
- Absolute neutrophil count greater than or equal to 1.5 X 109 /L.
- Platelet count greater than or equal to 100 X 109 /L.
- Partial thromboplastin time (PTT) and prothrombin time/international normalized ratio (PT/INR) within normal limits.
- Serum creatinine less than or equal to 1.5 mg/dL (135 µmol/L) or estimated creatinine clearance greater than 50 mL/min (calculated by the Cockcroft-Gault Formula).
- Total serum bilirubin less than or equal to 1.5 mg/dL.
- Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 X ULN.
- Sexually active males or females of reproductive capacity must use adequate contraception.
- For subjects with a history of coronary artery disease, stress test must be within normal limits.
- Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy must have a Multiple Gated Acquisition (MUGA) scan with a left ventricular ejection fraction of greater than 40%.
Exclusion Criteria:
- Women who are pregnant or are breast-feeding.
- Severe or uncontrolled infections requiring systemic antibiotic therapy.
- Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent.
- Known leptomeningeal disease or evidence of prior or current metastatic brain disease.
- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
- Receiving concurrent systemic steroids.
- History of ventricular arrhythmias requiring drug or device therapy.
- Any severe concurrent disease or condition, including significant autoimmune diseases, which in the judgment of the principal investigator, would make the subject inappropriate for study participation.
- Any unresolved or unstable serious toxicity from prior administration of another investigational drug.
- Any investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study.
- Received prior treatment with SB-485232.
- Poor venous access.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.
Time Frame: 11 Weeks
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11 Weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Biologically effective dose based. - Pharmacokinetic endpoints: AUC, Adverse Events, cmax, tmax, and t1/2. - Presence or absence of anti-SB-485232 antibodies. - Pharmacodynamic endpoints. - Radiographic tumor assessments.
Time Frame: 11 Weeks
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11 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Registration Dates
First Submitted
June 16, 2004
First Submitted That Met QC Criteria
June 17, 2004
First Posted (Estimate)
June 18, 2004
Study Record Updates
Last Update Posted (Estimate)
October 16, 2008
Last Update Submitted That Met QC Criteria
October 15, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 485232/002
- 002 (University of CT Health Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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