Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002904
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 ET-743 ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS
Status:
COMPLETED
Status Verified Date:
2012-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose MTD of ecteinascidin-743 ET-743 when administered as a single intravenous infusion every 21 days in adults with solid tumors not amenable to standard therapy II Describe the qualitative and quantitative toxic effects of ET-743 and study the predictability duration intensity onset reversibility and dose-relationship of these toxic effects in these patients III Propose a safe dose for a phase II study based on the MTD determined on this study IV Assess the pharmacokinetics of ET-743 at different dose levels V Document any antitumor effects of ET-743 in these patients
OUTLINE This is a multicenter study All patients receive ET-743 IV over 3 hours every 21 days for 4 courses Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ET-743 until the maximum tolerated dose is determined Patients are followed at 1 month then every 3 months until disease progression
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study over 12 months
OUTLINE This is a multicenter study All patients receive ET-743 IV over 3 hours every 21 days for 4 courses Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ET-743 until the maximum tolerated dose is determined Patients are followed at 1 month then every 3 months until disease progression
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study over 12 months
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 |
|---|---|---|---|
| EORTC-16951 | None | None | None |