Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276913
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2006-01-11
Brief Title:
A Phase I Study of STA-5312 in Subjects With Advanced or Metastatic Solid Tumors
Sponsor:
Synta Pharmaceuticals Corp
Organization:
Synta Pharmaceuticals Corp
Study Overview
Official Title:
A Phase I Study of STA-5312 Administered Weekly in Subjects With Advanced or Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 investigators 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 mgm2 The starting dose level was chosen based on preclinical animal studies that used alternate day dosing x 3week on alternate weeks The dose level of 6 mgm2 represents less than 110 the weekly dose 3 mgm2 x 3 that demonstrated severe toxicity Subsequent dose escalations will follow an accelerated titration design once the 8 mgm2 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
The initial dose level of STA 5312 will be 6 mgm2 The starting dose level was chosen based on preclinical animal studies that used alternate day dosing x 3week on alternate weeks The dose level of 6 mgm2 represents less than 110 the weekly dose 3 mgm2 x 3 that demonstrated severe toxicity Subsequent dose escalations will follow an accelerated titration design once the 8 mgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None