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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

Phase 1
18 Years
Not Enrolling
Solid Tumor Cancer

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Trial Information

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

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 ┬Ámol/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

- Sexually active males or females of reproductive capacity must use adequate

- 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

- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

- Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.

Outcome Time Frame:

11 Weeks

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Solid Tumor Cancer
  • IL-18
  • subcutaneous
  • pharmacokinetics
  • Phase 1
  • Neoplasms



GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Pittsburgh, Pennsylvania  15213