Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I, Open-Label, Dose-Escalation Study of SB-715992 Administered Days 1-3 of a 21-Day Cycle in Patients With Solid Tumors
This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of SB-715992 administered as a 1-hr intravenous
infusion on days 1-3 of a 21-day cycle in patients with solid tumors.
II. To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of
SB-715992 for this administration schedule.
SECONDARY OBJECTIVES:
I. To observe clinical response of SB-715992 given days 1-3, every 21-days. II. To
characterize the pharmacokinetics (PK) of SB-715992 for this administration schedule.
III. To explore drug metabolism, molecular and cellular predictors of efficacy (biomarkers)
and toxicity and drug interaction potential.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive SB-715992 IV over 1 hour on days 1-3. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SB-715992 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at
the MTD
Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 18-31 patients will be accrued for this study within 11-19
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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