Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006357
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-10-04
Brief Title:
STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma
PURPOSE Phase III trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma
PURPOSE Phase III trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and associated toxicity of STI571 in patients with refractory or recurrent soft tissue sarcoma II Determine the pharmacokinetic profile of this treatment regimen in these patients III Determine the objective response and duration of response in these patients with this treatment regimen
OUTLINE This is a dose escalation and dose efficacy multicenter study In the dose efficacy portion patients are stratified according to disease type gastrointestinal stromal tumor vs all other soft tissue sarcomas Phase I Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities The recommended phase II dose is defined as the dose preceding the MTD Phase II Patients receive the recommended phase II dose of STI571 as in phase I Patients are followed every 8 weeks until disease progression and then every 16 weeks thereafter
PROJECTED ACCRUAL Approximately 47-72 patients 7-32 in phase I and 40 in phase II will be accrued for this study
OUTLINE This is a dose escalation and dose efficacy multicenter study In the dose efficacy portion patients are stratified according to disease type gastrointestinal stromal tumor vs all other soft tissue sarcomas Phase I Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities The recommended phase II dose is defined as the dose preceding the MTD Phase II Patients receive the recommended phase II dose of STI571 as in phase I Patients are followed every 8 weeks until disease progression and then every 16 weeks thereafter
PROJECTED ACCRUAL Approximately 47-72 patients 7-32 in phase I and 40 in phase II will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOVARTIS-CSTI5710203 | None | None | None |
| EORTC-62001 | None | None | None |
| EORTC-16003 | None | None | None |