A Phase I Study of STA-5312 Administered Weekly in Subjects With Advanced or Metastatic Solid Tumors
This is a Phase I open-label, dose-escalation safety study in subjects with refractory non
hematologic malignancies. STA-5312 will be administered intravenously. Administration is
anticipated to take 1 hour, although infusion time may be extended when appropriate with
large infusion volumes. A treatment cycle is 4 weeks with a weekly infusion of STA 5312 for
the first 3 weeks of each 4 week cycle. The planned treatment schedule is 2 cycles of
STA-5312 treatment (8 weeks). Decisions regarding dose escalation and DLT determination
will be made based on observations during the first cycle of therapy. Subjects who tolerate
treatment may be eligible to continue receiving additional cycles of STA 5312 per the
investigator’s medical judgment. Evaluation of antitumor response will be performed after
every 2 cycles of STA 5312 administration.
The initial dose level of STA 5312 will be 6 mg/m2. The starting dose level was chosen
based on preclinical animal studies that used alternate day dosing x 3/week on alternate
weeks. The dose level of 6 mg/m2 represents less than 1/10 the weekly dose (3 mg/m2 x 3)
that demonstrated severe toxicity. Subsequent dose escalations will follow an accelerated
titration design once the 8 mg/m2 cohort is completed No fewer than 3 patients will be
enrolled at each dose level. Once a DLT is observed the cohort will be expanded to at least
six subjects. If one-third of at least 6 subjects treated at a dose level experience a DLT,
dose escalation will terminate. The dose below this will be considered the MTD and will be
expanded to at least 12 subjects to collect additional safety and pharmacokinetic data. No
intrasubject dose escalations will occur.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
5312-02
NCT00276913
June 2004
Name | Location |
---|---|
Steven Limentani, MD | Charlotte, North Carolina 28203 |