NCT00276913

A Phase I Study of STA-5312 in Subjects With Advanced or Metastatic Solid Tumors

A Phase I Study of STA-5312 Administered Weekly in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Synta Pharmaceuticals Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: * To determine the safety, toxicity and the maximum tolerated dose (MTD) of intravenous STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic solid tumors. * To determine the pharmacokinetics of STA-5312. Secondary Objective: • To assess antitumor activity of STA-5312 administration.

Detailed description

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.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	STA-5312

Timeline

• Start date: 2004-06-01
• First posted: 2006-01-13
• Last updated: 2014-02-03

Locations

1 site across 1 country: United States