Status:
COMPLETED
Dose-Escalation Study Of SB-485232 Administered As Daily Subcutaneous Injections In Adults With Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Solid Tumor Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00085878
Start Date
January 1 2003
Last Update
October 16 2008
Active Locations (4)
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1
GSK Investigational Site
Santa Monica, California, United States, 90404-2104
2
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
3
GSK Investigational Site
Durham, North Carolina, United States, 27705
4
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111