A PHASE 1 STUDY OF ISPINESIB (SB-715992) IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY SOLID TUMORS
I. Determine the maximum tolerated dose and recommended phase II dose of ispinesib in
pediatric patients with refractory solid tumors or lymphoma.
II. Define and describe the toxicities of ispinesib in these patients. III. Characterize the
pharmacokinetics of ispinesib in these patients.
I. Define, preliminarily, the antitumor activity of ispinesib. II. Determine the
relationship between CYP3A4 gene polymorphisms and pharmacokinetics in patients treated with
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive ispinesib IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28
days for 24 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ispinesib 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.
Patients undergo blood and tumor sample collection periodically for pharmacokinetic and gene
polymorphism correlative studies.
After completion of study therapy, patients are followed for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose, defined as the maximum dose at which fewer than one-third of patients experience DLT, graded according to NCI CTCAE version 3.0
Up to 28 days
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|