Dose-Escalation Study Of SB-485232 Administered As Daily Subcutaneous Injections In Adults With Solid Tumors
This study is currently recruiting patients.
Sponsored by: |
GlaxoSmithKline |
Information provided by: |
GlaxoSmithKline |
Purpose
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.
Condition
|
Treatment or Intervention |
Phase |
Solid Tumors
|
Drug: SB-485232
|
Phase I
|
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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 (KSP) 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.
Location
and Contact
Information
North Carolina Durham,
North Carolina,
27705,
United States; Recruiting
Study Coordinator
919-970-7334
Pennsylvania Philadelphia,
Pennsylvania,
19111,
United States; Recruiting
Study Coordinator
215-728-5715
More Information
Study ID Numbers:
485232/002
Record last reviewed:
July 2004
Record first received:
June 16, 2004
ClinicalTrials.gov Identifier:
NCT00085878Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10